Estradiol Transdermal Patch

Brand(s)
Alora, Climara, Menostar, Minivelle, Vivelle
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bayer Healthcare Pharmaceuticals Inc. (2015-07-23)
Oldest Current Product
1996-12-20
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
TRANSDERMAL PATCH\ESTRADIOL
FDAOB
TRANSDERMAL\FILM, EXTENDED RELEASE\ESTRADIOL
SPL Active
TRANSDERMAL\FILM, EXTENDED RELEASE\ESTRADIOL
TRANSDERMAL\PATCH, EXTENDED RELEASE\ESTRADIOL
TRANSDERMAL\PATCH\ESTRADIOL
SPL Moiety
TRANSDERMAL\FILM, EXTENDED RELEASE\ESTRADIOL
TRANSDERMAL\PATCH, EXTENDED RELEASE\ESTRADIOL
TRANSDERMAL\PATCH\ESTRADIOL

product(s) by strength(s)

168 hr estradiol 0.000583 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190455MenostarNDABayer Healthcare Pharmaceuticals Inc.2004-06-08ESTRADIOLTRANSDERMALPATCHNDA020375a78708cd-04d4-4221-a4e4-53680bbe2912

84 hr estradiol 0.00104 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780365VivelleNDANovartis Pharmaceuticals Corporation1999-01-08ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASENDA020538e6f2e7ed-41a9-4a53-ac80-0cb1fa2edcbf
2525440884AloraNDAActavis Pharma, Inc.2002-04-05ESTRADIOLTRANSDERMALPATCHNDA020655a0d4f0b8-5dcc-4ffe-9590-0203e869622f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784644ANDAMylan Pharmaceuticals Inc.2014-12-19ESTRADIOLTRANSDERMALPATCHANDA201675d28bec8f-762e-4f05-a20d-96a42970d6a7
2007817129NDA AUTHORIZED GENERICSandoz Inc2014-12-22ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASENDA020538c4da6de7-9ab1-4fcf-88f3-fe785019e6e7

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684862VivelleNDAPhysicians Total Care, Inc.2003-07-232005-06-30ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASE000780365NDA02053803ab0226-b494-4607-8e8b-7381082fa780

168 hr estradiol 0.00104 mg/hr transdermal patch

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1477810204NDAAlvogen, Inc.2011-12-20ESTRADIOLTRANSDERMALPATCHNDA02037592eafd85-0051-44af-ba5c-9194c8deffe2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783349ANDAMylan Pharmaceuticals Inc.2005-03-28ESTRADIOLTRANSDERMALPATCHANDA075182e7e6da3b-8485-1382-61c9-e9b369018b98

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685009ANDAPhysicians Total Care, Inc.2008-12-11ESTRADIOLTRANSDERMALPATCH003783350ANDA075182396686ba-ab8d-4223-80e7-9c4f7ddb7852

84 hr estradiol 0.00156 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1689686637MinivelleNDANoven Therapeutics, Llc2012-12-20ESTRADIOLTRANSDERMALFILM, EXTENDED RELEASENDA2037526c5c47ab-28ee-11e1-bfc2-0800200c9a66

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784643ANDAMylan Pharmaceuticals Inc.2014-12-19ESTRADIOLTRANSDERMALPATCHANDA201675d28bec8f-762e-4f05-a20d-96a42970d6a7
2007817138NDA AUTHORIZED GENERICSandoz Inc2014-12-22ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASENDA020538c4da6de7-9ab1-4fcf-88f3-fe785019e6e7

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684920VivelleNDAPhysicians Total Care, Inc.2003-09-23ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASE000780343NDA02053803ab0226-b494-4607-8e8b-7381082fa780

168 hr estradiol 0.00156 mg/hr transdermal patch

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1477810205NDAAlvogen, Inc.2011-12-20ESTRADIOLTRANSDERMALPATCHNDA02037592eafd85-0051-44af-ba5c-9194c8deffe2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783360ANDAMylan Pharmaceuticals Inc.2006-08-10ESTRADIOLTRANSDERMALPATCHANDA075182e7e6da3b-8485-1382-61c9-e9b369018b98

168 hr estradiol 0.00208 mg/hr transdermal patch

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1477810206NDAAlvogen, Inc.2011-12-20ESTRADIOLTRANSDERMALPATCHNDA02037592eafd85-0051-44af-ba5c-9194c8deffe2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783350ANDAMylan Pharmaceuticals Inc.2000-02-24ESTRADIOLTRANSDERMALPATCHANDA075182e7e6da3b-8485-1382-61c9-e9b369018b98

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684811ANDAPhysicians Total Care, Inc.2003-06-14ESTRADIOLTRANSDERMALPATCH003783349ANDA075182396686ba-ab8d-4223-80e7-9c4f7ddb7852

84 hr estradiol 0.00208 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440471AloraNDAActavis Pharma, Inc.1996-12-20ESTRADIOLTRANSDERMALPATCHNDA020655a0d4f0b8-5dcc-4ffe-9590-0203e869622f
2689686650MinivelleNDANoven Therapeutics, Llc2012-12-20ESTRADIOLTRANSDERMALFILM, EXTENDED RELEASENDA2037526c5c47ab-28ee-11e1-bfc2-0800200c9a66

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784642ANDAMylan Pharmaceuticals Inc.2014-12-19ESTRADIOLTRANSDERMALPATCHANDA201675d28bec8f-762e-4f05-a20d-96a42970d6a7
2007817144NDA AUTHORIZED GENERICSandoz Inc2014-12-22ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASENDA020538c4da6de7-9ab1-4fcf-88f3-fe785019e6e7

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684242VivelleNDAPhysicians Total Care, Inc.2003-06-10ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASE000780344NDA02053803ab0226-b494-4607-8e8b-7381082fa780

168 hr estradiol 0.0025 mg/hr transdermal patch

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1477810207NDAAlvogen, Inc.2011-12-20ESTRADIOLTRANSDERMALPATCHNDA02037592eafd85-0051-44af-ba5c-9194c8deffe2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783361ANDAMylan Pharmaceuticals Inc.2006-08-10ESTRADIOLTRANSDERMALPATCHANDA075182e7e6da3b-8485-1382-61c9-e9b369018b98

168 hr estradiol 0.00312 mg/hr transdermal patch

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1477810208NDAAlvogen, Inc.2011-12-20ESTRADIOLTRANSDERMALPATCHNDA02037592eafd85-0051-44af-ba5c-9194c8deffe2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783351ANDAMylan Pharmaceuticals Inc.2005-03-28ESTRADIOLTRANSDERMALPATCHANDA075182e7e6da3b-8485-1382-61c9-e9b369018b98

84 hr estradiol 0.00313 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780345VivelleNDANovartis Pharmaceuticals Corporation1999-01-08ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASENDA020538e6f2e7ed-41a9-4a53-ac80-0cb1fa2edcbf
2689686675MinivelleNDANoven Therapeutics, Llc2012-12-20ESTRADIOLTRANSDERMALFILM, EXTENDED RELEASENDA2037526c5c47ab-28ee-11e1-bfc2-0800200c9a66

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784641ANDAMylan Pharmaceuticals Inc.2014-12-19ESTRADIOLTRANSDERMALPATCHANDA201675d28bec8f-762e-4f05-a20d-96a42970d6a7
2007817156NDA AUTHORIZED GENERICSandoz Inc2014-12-22ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASENDA020538c4da6de7-9ab1-4fcf-88f3-fe785019e6e7

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684243VivelleNDAPhysicians Total Care, Inc.2003-06-10ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASE000780345NDA02053803ab0226-b494-4607-8e8b-7381082fa780

168 hr estradiol 0.00417 mg/hr transdermal patch

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1477810209NDAAlvogen, Inc.2011-12-19ESTRADIOLTRANSDERMALPATCHNDA02037592eafd85-0051-44af-ba5c-9194c8deffe2

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003783352ANDAMylan Pharmaceuticals Inc.2000-02-24ESTRADIOLTRANSDERMALPATCHANDA075182e7e6da3b-8485-1382-61c9-e9b369018b98

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684813ANDAPhysicians Total Care, Inc.2003-06-09ESTRADIOLTRANSDERMALPATCH003783360ANDA075182396686ba-ab8d-4223-80e7-9c4f7ddb7852

84 hr estradiol 0.00417 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780346VivelleNDANovartis Pharmaceuticals Corporation1999-01-08ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASENDA020538e6f2e7ed-41a9-4a53-ac80-0cb1fa2edcbf
2689686610MinivelleNDANoven Therapeutics, Llc2012-12-20ESTRADIOLTRANSDERMALFILM, EXTENDED RELEASENDA2037526c5c47ab-28ee-11e1-bfc2-0800200c9a66

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003784640ANDAMylan Pharmaceuticals Inc.2014-12-19ESTRADIOLTRANSDERMALPATCHANDA201675d28bec8f-762e-4f05-a20d-96a42970d6a7
2007817167NDA AUTHORIZED GENERICSandoz Inc2014-12-22ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASENDA020538c4da6de7-9ab1-4fcf-88f3-fe785019e6e7

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684244VivelleNDAPhysicians Total Care, Inc.2003-06-10ESTRADIOLTRANSDERMALPATCH, EXTENDED RELEASE000780346NDA02053803ab0226-b494-4607-8e8b-7381082fa780

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA075182ESTRADIOLMYLAN TECHNOLOGIES INC2000-02-24ANDA075182_001, ANDA075182_002, ANDA075182_003, ANDA075182_004, ANDA075182_005, ANDA075182_006
2ANDA201675ESTRADIOLMYLAN TECHNOLOGIES INC2014-12-19ANDA201675_001, ANDA201675_002, ANDA201675_003, ANDA201675_004, ANDA201675_005
3NDA019081ESTRADERMNOVARTIS PHARMACEUTICALS CORP1986-09-10NDA019081_002, NDA019081_003
4NDA020323VIVELLENOVARTIS PHARMACEUTICALS CORP1994-10-28NDA020323_001, NDA020323_002, NDA020323_003, NDA020323_004, NDA020323_005
5NDA020375CLIMARABAYER HEALTHCARE PHARMACEUTICALS INC1994-12-22NDA020375_001, NDA020375_002, NDA020375_003, NDA020375_004, NDA020375_005, NDA020375_006
6NDA020417FEMPATCHTruePARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO1996-12-03NDA020417_001
7NDA020538VIVELLE-DOTNOVARTIS PHARMACEUTICALS CORP1999-01-08p5656286, SUBSTANCENDA020538_005, NDA020538_006, NDA020538_007, NDA020538_008, NDA020538_009
8NDA020655ALORAACTAVIS LABORATORIES UT INC1996-12-20NDA020655_001, NDA020655_002, NDA020655_003, NDA020655_004
9NDA020847ESCLIMTrueWOMEN FIRST HEALTHCARE INC1998-08-04NDA020847_001, NDA020847_002, NDA020847_003, NDA020847_004, NDA020847_005
10NDA021048ESTRADIOLTrueORTHO MCNEIL PHARMACEUTICAL INC1999-09-20NDA021048_001, NDA021048_002, NDA021048_003
11NDA021674MENOSTARBAYER HEALTHCARE PHARMACEUTICALS INC2004-06-08p5891868, PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS, SUBSTANCE
p6692763, PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS, SUBSTANCE
NDA021674_001
12NDA203752MINIVELLENOVEN PHARMACEUTICALS INC2012-10-29p5656286, SUBSTANCE
p8231906, SUBSTANCE
p6841716, SUBSTANCE
NDA203752_001, NDA203752_002, NDA203752_003, NDA203752_004, NDA203752_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075182_001RXESTRADIOL (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB22000-02-24ESTRADIOL
2ANDA075182_002RXESTRADIOL (0.075MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB22005-01-26ESTRADIOL
3ANDA075182_003RXESTRADIOL (0.025MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB22005-01-26ESTRADIOL
4ANDA075182_004RXESTRADIOL (0.0375MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2006-07-20ESTRADIOL
5ANDA075182_005RXESTRADIOL (0.06MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2006-07-20ESTRADIOL
6ANDA075182_006RXESTRADIOL (0.05MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB22000-02-24ESTRADIOL
7ANDA201675_001RXESTRADIOL (0.025MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB12014-12-19ESTRADIOL
8ANDA201675_002RXESTRADIOL (0.0375MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB12014-12-19ESTRADIOL
9ANDA201675_003RXESTRADIOL (0.05MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB12014-12-19ESTRADIOL
10ANDA201675_004RXESTRADIOL (0.075MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB12014-12-19ESTRADIOL
11ANDA201675_005RXESTRADIOL (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB12014-12-19ESTRADIOL
12NDA019081_002RXESTRADIOL (0.05MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseBX1986-09-10ESTRADERM
13NDA019081_003RXESTRADIOL (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASETrueBX1986-09-10ESTRADERM
14NDA020323_001discontinuedESTRADIOL (0.0375MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1994-10-28VIVELLE
15NDA020323_002RXESTRADIOL (0.05MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB11994-10-28VIVELLE
16NDA020323_003discontinuedESTRADIOL (0.075MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1994-10-28VIVELLE
17NDA020323_004RXESTRADIOL (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB11994-10-28VIVELLE
18NDA020323_005discontinuedESTRADIOL (0.025MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse2000-08-16VIVELLE
19NDA020375_001RXESTRADIOL (0.05MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB21994-12-22CLIMARA
20NDA020375_002RXESTRADIOL (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASETrueAB21994-12-22CLIMARA
21NDA020375_003RXESTRADIOL (0.075MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB21998-03-23CLIMARA
22NDA020375_004RXESTRADIOL (0.025MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB21999-03-05CLIMARA
23NDA020375_005RXESTRADIOL (0.0375MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2003-05-27CLIMARA
24NDA020375_006RXESTRADIOL (0.06MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2003-05-27CLIMARA
25NDA020417_001discontinuedESTRADIOL (0.025MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1996-12-03FEMPATCH
26NDA020538_005RXESTRADIOL (0.0375MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB11999-01-08VIVELLE-DOT
27NDA020538_006RXESTRADIOL (0.05MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB11999-01-08VIVELLE-DOT
28NDA020538_007RXESTRADIOL (0.075MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB11999-01-08VIVELLE-DOT
29NDA020538_008RXESTRADIOL (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASETrueAB11999-01-08VIVELLE-DOT
30NDA020538_009RXESTRADIOL (0.025MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB12002-05-03VIVELLE-DOT
31NDA020655_001RXESTRADIOL (0.05MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseBX1996-12-20ALORA
32NDA020655_002RXESTRADIOL (0.075MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseBX1996-12-20ALORA
33NDA020655_003RXESTRADIOL (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseBX1996-12-20ALORA
34NDA020655_004RXESTRADIOL (0.025MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseBX2002-04-05ALORA
35NDA020847_001discontinuedESTRADIOL (0.025MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1998-08-04ESCLIM
36NDA020847_002discontinuedESTRADIOL (0.0375MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1998-08-04ESCLIM
37NDA020847_003discontinuedESTRADIOL (0.05MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1998-08-04ESCLIM
38NDA020847_004discontinuedESTRADIOL (0.075MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1998-08-04ESCLIM
39NDA020847_005discontinuedESTRADIOL (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1998-08-04ESCLIM
40NDA021048_001discontinuedESTRADIOL (0.05MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1999-09-20ESTRADIOL
41NDA021048_002discontinuedESTRADIOL (0.075MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1999-09-20ESTRADIOL
42NDA021048_003discontinuedESTRADIOL (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse1999-09-20ESTRADIOL
43NDA021674_001RXESTRADIOL (0.014MG/24HR)TRANSDERMALFILM, EXTENDED RELEASETrue2004-06-08MENOSTAR
44NDA203752_001RXESTRADIOL (0.0375MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse2012-10-29MINIVELLE
45NDA203752_002RXESTRADIOL (0.075MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse2012-10-29MINIVELLE
46NDA203752_003RXESTRADIOL (0.05MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse2012-10-29MINIVELLE
47NDA203752_004RXESTRADIOL (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASETrue2012-10-29MINIVELLE
48NDA203752_005RXESTRADIOL (0.025MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalse2014-09-23MINIVELLE

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5656286 (view patent)2014-08-12NDA020538, NDA203752, NDA020870Estradiol / Norethindrone Transdermal Patch
2p5891868 (view patent)2017-11-21NDA021674
3p6692763 (view patent)2017-11-21NDA021674
4p6841716 (view patent)2020-04-27NDA203752
5p8231906 (view patent)2030-07-04NDA203752

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
103ab0226-b494-4607-8e8b-7381082fa780 (view SPL)Vivelle-DotprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-02-171548684242, 548684243, 548684244, 548684862, 548684920
21e9702c4-f2d7-4ea8-b6e8-7dca31671864 (view SPL)These highlights do not include all the information needed to use CLIMARA safely and effectively. See full prescribing information for CLIMARA. Climara (estradiol transdermal system) Initial U.S. Approval: 1975prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.MANUFACTURE2015-07-208504190451, 504190452, 504190453, 504190454, 504190456, 504190459
3396686ba-ab8d-4223-80e7-9c4f7ddb7852 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-01-182548684811, 548684813, 548685009
46c5c47ab-28ee-11e1-bfc2-0800200c9a66 (view SPL)These highlights do not include all the information needed to use MINIVELLE safely and effectively. See full prescribing information for MINIVELLE. MINIVELLE (estradiol transdermal system) Initial U.S. Approval: 1975prescriptionHuman PrescriptionNoven Therapeutics, LlcMANUFACTURE2014-09-304689686610, 689686637, 689686650, 689686675, 689686625
592eafd85-0051-44af-ba5c-9194c8deffe2 (view SPL)These highlights do not include all the information needed to use the ESTRADIOL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for the ESTRADIOL TRANSDERMAL SYSTEM. ESTRADIOL TRANSDERMAL SYSTEM (estradiol transdermal system) Initial U.S. Approval: 1975prescriptionHuman PrescriptionAlvogen, Inc.MANUFACTURE2013-10-133477810204, 477810205, 477810206, 477810207, 477810208, 477810209
6a0d4f0b8-5dcc-4ffe-9590-0203e869622f (view SPL)Alora (Estradiol Transdermal System, USP)Continuous Delivery for Twice Weekly DosingContent Updated: August 2014Rx only200178-13Prescribing Information With Attached Patient Information Leaflet PRESCRIBING INFORMATIONprescriptionHuman PrescriptionActavis Pharma, Inc.2015-01-167525440471, 525440884, 525440472, 525440473
7a78708cd-04d4-4221-a4e4-53680bbe2912 (view SPL)These highlights do not include all the information needed to use MENOSTAR safely and effectively. See full prescribing information for MENOSTAR.Menostar (estradiol transdermal system)Initial U.S. Approval: 1975prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.MANUFACTURE2015-07-235504190455
8c4da6de7-9ab1-4fcf-88f3-fe785019e6e7 (view SPL)These highlights do not include all the information needed to use ESTRADIOL TRANSDERMAL SYSTEM safely and effectively. See full prescribing information for ESTRADIOL TRANSDERMAL SYSTEM.ESTRADIOL TRANSDERMAL SYSTEMInitial U.S. Approval: 1996prescriptionHuman PrescriptionSandoz Inc2014-12-231007817129, 007817138, 007817144, 007817156, 007817167
9d28bec8f-762e-4f05-a20d-96a42970d6a7 (view SPL)These highlights do not include all the information needed to use ESTRADIOL transdermal system (twice-weekly) safely and effectively. See full prescribing information for ESTRADIOL transdermal system (twice-weekly). ESTRADIOL transdermal system, USP (twice-weekly) Initial U.S. Approval: 1996prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-08-134003784640, 003784641, 003784642, 003784643, 003784644
10e6f2e7ed-41a9-4a53-ac80-0cb1fa2edcbf (view SPL)These highlights do not include all the information needed to use VIVELLE-DOT safely and effectively. See full prescribing information for VIVELLE-DOT. VIVELLE-DOT (estradiol transdermal system) Initial U.S. Approval: 1996prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2014-07-315000780345, 000780346, 000780365, 000780343, 000780344
11e7e6da3b-8485-1382-61c9-e9b369018b98 (view SPL)These highlights do not include all the information needed to use estradiol transdermal system continuous delivery (once-weekly) safely and effectively. See full prescribing information for estradiol transdermal system continuous delivery (once-weekly). ESTRADIOL transdermal system, USP continuous delivery (once-weekly)Initial U.S. Approval: 1975prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-05-129003783349, 003783350, 003783351, 003783352, 003783360, 003783361

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII