Clonidine Transdermal Patch

Brand(s)
Catapres-TTS-1, Catapres-TTS-2, Catapres-TTS-3
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2012-06-15)
Oldest Current Product
1985-10-01
License(s)
NDA, ANDA
RxNORM
TRANSDERMAL PATCH\CLONIDINE
FDAOB
TRANSDERMAL\FILM, EXTENDED RELEASE\CLONIDINE
SPL Active
TRANSDERMAL\PATCH, EXTENDED RELEASE\CLONIDINE
TRANSDERMAL\PATCH\CLONIDINE
SPL Moiety
TRANSDERMAL\PATCH, EXTENDED RELEASE\CLONIDINE
TRANSDERMAL\PATCH\CLONIDINE

product(s) by strength(s)

168 hr clonidine 0.00417 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970031Catapres-TTS-1NDABoehringer Ingelheim Pharmaceuticals, Inc.1985-10-01CLONIDINETRANSDERMALPATCH, EXTENDED RELEASENDA018891fe0f5dcb-65dd-4d31-80d6-8b97eb040063

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780871ANDAMylan Pharmaceuticals Inc.2013-02-08CLONIDINETRANSDERMALPATCHANDA0761667adfc439-e6d0-4593-87dd-0eef36d33c6d
2005551009ANDABarr Laboratories Inc.2010-08-25CLONIDINETRANSDERMALPATCH, EXTENDED RELEASEANDA0790906d63d646-63a0-4a35-aced-ea06bd10c410
3005913508ANDAWatson Laboratories, Inc.2014-05-06CLONIDINETRANSDERMALPATCHANDA09087399a59495-2a48-4276-bbe3-cdd55a45aba4

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950567Catapres-TTS-1NDARebel Distributors Corp1985-10-01CLONIDINETRANSDERMALPATCH, EXTENDED RELEASE005970031NDA018891f4ac82b0-d0fb-4720-a277-5b2b8013cb3f
2548686310ANDAPhysicians Total Care, Inc.2011-09-24CLONIDINETRANSDERMALPATCH498840774ANDA076157996d9246-e5d2-48a2-be8d-9ef5c8f64b1c

168 hr clonidine 0.00833 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970032Catapres-TTS-2NDABoehringer Ingelheim Pharmaceuticals, Inc.1985-10-01CLONIDINETRANSDERMALPATCH, EXTENDED RELEASENDA018891fe0f5dcb-65dd-4d31-80d6-8b97eb040063

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780872ANDAMylan Pharmaceuticals Inc.2013-02-08CLONIDINETRANSDERMALPATCHANDA0761667adfc439-e6d0-4593-87dd-0eef36d33c6d
2005551010ANDABarr Laboratories Inc.2010-08-25CLONIDINETRANSDERMALPATCH, EXTENDED RELEASEANDA0790906d63d646-63a0-4a35-aced-ea06bd10c410
3005913509ANDAWatson Laboratories, Inc.2014-05-06CLONIDINETRANSDERMALPATCHANDA09087399a59495-2a48-4276-bbe3-cdd55a45aba4

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560806ANDALake Erie Medical Dba Quality Care Products Llc2010-08-25CLONIDINETRANSDERMALPATCH, EXTENDED RELEASE005551010ANDA07909000f30ef0-e65c-4b41-ad1b-afaab9bcfc7d
2548686214ANDAPhysicians Total Care, Inc.2010-12-14CLONIDINETRANSDERMALPATCH498840775ANDA076157996d9246-e5d2-48a2-be8d-9ef5c8f64b1c
3557000027ANDALake Erie Medical Dba Quality Care Products Llc2013-02-08CLONIDINETRANSDERMALPATCH003780872ANDA0761663af488f5-0058-4f7d-b3af-e424404f1a95

168 hr clonidine 0.0125 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970033Catapres-TTS-3NDABoehringer Ingelheim Pharmaceuticals, Inc.1985-10-01CLONIDINETRANSDERMALPATCH, EXTENDED RELEASENDA018891fe0f5dcb-65dd-4d31-80d6-8b97eb040063

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780873ANDAMylan Pharmaceuticals Inc.2013-02-08CLONIDINETRANSDERMALPATCHANDA0761667adfc439-e6d0-4593-87dd-0eef36d33c6d
2005551011ANDABarr Laboratories Inc.2010-08-25CLONIDINETRANSDERMALPATCH, EXTENDED RELEASEANDA0790906d63d646-63a0-4a35-aced-ea06bd10c410
3005913510ANDAWatson Laboratories, Inc.2014-05-06CLONIDINETRANSDERMALPATCHANDA09087399a59495-2a48-4276-bbe3-cdd55a45aba4

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686260ANDAPhysicians Total Care, Inc.2011-05-10CLONIDINETRANSDERMALPATCH498840776ANDA076157996d9246-e5d2-48a2-be8d-9ef5c8f64b1c

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA076157CLONIDINEAVEVA DRUG DELIVERY SYSTEMS INC2009-08-18ANDA076157_001, ANDA076157_002, ANDA076157_003
2ANDA076166CLONIDINEMYLAN TECHNOLOGIES INC2010-07-16ANDA076166_001, ANDA076166_002, ANDA076166_003
3ANDA079090CLONIDINEBARR LABORATORIES INC2010-08-20ANDA079090_001, ANDA079090_002, ANDA079090_003
4ANDA090873CLONIDINEACTAVIS LABORATORIES UT INC2014-05-06ANDA090873_001, ANDA090873_002, ANDA090873_003
5NDA018891CATAPRES-TTS-1BOEHRINGER INGELHEIM1984-10-10NDA018891_001, NDA018891_002, NDA018891_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076157_001RXCLONIDINE (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2009-08-18CLONIDINE
2ANDA076157_002RXCLONIDINE (0.2MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2009-08-18CLONIDINE
3ANDA076157_003RXCLONIDINE (0.3MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2009-08-18CLONIDINE
4ANDA076166_001RXCLONIDINE (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2010-07-16CLONIDINE
5ANDA076166_002RXCLONIDINE (0.2MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2010-07-16CLONIDINE
6ANDA076166_003RXCLONIDINE (0.3MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2010-07-16CLONIDINE
7ANDA079090_001RXCLONIDINE (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2010-08-20CLONIDINE
8ANDA079090_002RXCLONIDINE (0.2MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2010-08-20CLONIDINE
9ANDA079090_003RXCLONIDINE (0.3MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2010-08-20CLONIDINE
10ANDA090873_001RXCLONIDINE (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2014-05-06CLONIDINE
11ANDA090873_002RXCLONIDINE (0.2MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2014-05-06CLONIDINE
12ANDA090873_003RXCLONIDINE (0.3MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB2014-05-06CLONIDINE
13NDA018891_001RXCLONIDINE (0.1MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB1984-10-10CATAPRES-TTS-1
14NDA018891_002RXCLONIDINE (0.2MG/24HR)TRANSDERMALFILM, EXTENDED RELEASEFalseAB1984-10-10CATAPRES-TTS-1
15NDA018891_003RXCLONIDINE (0.3MG/24HR)TRANSDERMALFILM, EXTENDED RELEASETrueAB1984-10-10CATAPRES-TTS-1

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
100f30ef0-e65c-4b41-ad1b-afaab9bcfc7d (view SPL)CLONIDINE Transdermal System USPProgrammed delivery in vivo of 0.1, 0.2, or 0.3 mg clonidine USP per day, for one week.prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2013-01-311353560806
23af488f5-0058-4f7d-b3af-e424404f1a95 (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2015-03-241557000027
36d63d646-63a0-4a35-aced-ea06bd10c410 (view SPL)CLONIDINE Transdermal System USPProgrammed delivery in vivo of 0.1, 0.2, or 0.3 mg clonidine USP per day, for one week.prescriptionHuman PrescriptionBarr Laboratories Inc.2013-06-264005551009, 005551010, 005551011
47adfc439-e6d0-4593-87dd-0eef36d33c6d (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2013-01-318003780871, 003780872, 003780873
5996d9246-e5d2-48a2-be8d-9ef5c8f64b1c (view SPL)Clonidine Transdermal System(clonidine)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-12-295548686214, 548686260, 548686310
699a59495-2a48-4276-bbe3-cdd55a45aba4 (view SPL)Clonidine Transdermal System USPprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-01-014005913508, 005913509, 005913510
7f4ac82b0-d0fb-4720-a277-5b2b8013cb3f (view SPL)Catapres-TTS -1prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-101216950567
8fe0f5dcb-65dd-4d31-80d6-8b97eb040063 (view SPL)Catapres-TTS (clonidine)Catapres-TTS -1 Catapres-TTS -2 Catapres-TTS -3prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2012-06-157005970031, 005970032, 005970033

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