estropipate Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2012-07-30)
Oldest Current Product
1993-09-23
License(s)
ANDA
RxNORM
ORAL TABLET\ESTROPIPATE
FDAOB
ORAL\TABLET\ESTROPIPATE
SPL Active
ORAL\TABLET\ESTROPIPATE
SPL Moiety
ORAL\TABLET\ESTRONE
ORAL\TABLET\ESTROPIPATE

product(s) by strength(s)

estropipate 0.75 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005910414ANDAWatson Laboratories, Inc.1993-09-23ESTROPIPATEORALTABLETANDA0812134252d631-03d0-4b37-8a0e-c7dc8fc5438a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548683114ANDAPhysicians Total Care, Inc.2003-03-21ESTROPIPATEORALTABLET525440414ANDA08121303cdbf5b-b572-448f-80e9-b3e812959901

estropipate 1.5 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005910415ANDAWatson Laboratories, Inc.1993-09-23ESTROPIPATEORALTABLETANDA0812144252d631-03d0-4b37-8a0e-c7dc8fc5438a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684149ANDAPhysicians Total Care, Inc.2003-03-21ESTROPIPATEORALTABLET525440415ANDA08121403cdbf5b-b572-448f-80e9-b3e812959901

estropipate 3 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005910416ANDAWatson Laboratories, Inc.1993-09-23ESTROPIPATEORALTABLETANDA0812154252d631-03d0-4b37-8a0e-c7dc8fc5438a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684761ANDAPhysicians Total Care, Inc.2003-03-26ESTROPIPATEORALTABLET525440416ANDA08121503cdbf5b-b572-448f-80e9-b3e812959901

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040135ESTROPIPATEBARR LABORATORIES INC1996-11-27ANDA040135_001, ANDA040135_002, ANDA040135_003
2ANDA040296ESTROPIPATETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1999-11-01ANDA040296_001, ANDA040296_002, ANDA040296_003
3ANDA040359ESTROPIPATEMYLAN PHARMACEUTICALS INC1999-08-26ANDA040359_001, ANDA040359_002, ANDA040359_003
4ANDA081213ESTROPIPATEWATSON LABORATORIES INC1993-09-23ANDA081213_001
5ANDA081214ESTROPIPATEWATSON LABORATORIES INC1993-09-23ANDA081214_001
6ANDA081215ESTROPIPATEWATSON LABORATORIES INC1993-09-23ANDA081215_001
7ANDA081216ESTROPIPATETrueWATSON LABORATORIES INC1993-09-23ANDA081216_001
8ANDA083220OGEN .625PHARMACIA AND UPJOHN COANDA083220_001, ANDA083220_002, ANDA083220_003, ANDA083220_004
9ANDA089567ORTHO-ESTTrueSUN PHARMACEUTICAL INDUSTRIES INC1991-02-27ANDA089567_001
10ANDA089582ORTHO-ESTTrueSUN PHARMACEUTICAL INDUSTRIES INC1991-07-17ANDA089582_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040135_001RXESTROPIPATE (0.75MG)ORALTABLETFalseAB1996-11-27ESTROPIPATE
2ANDA040135_002RXESTROPIPATE (1.5MG)ORALTABLETFalseAB1996-11-27ESTROPIPATE
3ANDA040135_003RXESTROPIPATE (3MG)ORALTABLETFalseAB1996-11-27ESTROPIPATE
4ANDA040296_001discontinuedESTROPIPATE (0.75MG)ORALTABLETFalse1999-11-01ESTROPIPATE
5ANDA040296_002discontinuedESTROPIPATE (1.5MG)ORALTABLETFalse1999-11-01ESTROPIPATE
6ANDA040296_003discontinuedESTROPIPATE (3MG)ORALTABLETFalse1999-11-01ESTROPIPATE
7ANDA040359_001RXESTROPIPATE (0.75MG)ORALTABLETFalseAB1999-08-26ESTROPIPATE
8ANDA040359_002RXESTROPIPATE (1.5MG)ORALTABLETFalseAB1999-08-26ESTROPIPATE
9ANDA040359_003discontinuedESTROPIPATE (3MG)ORALTABLETFalse1999-08-26ESTROPIPATE
10ANDA081213_001RXESTROPIPATE (0.75MG)ORALTABLETFalseAB1993-09-23ESTROPIPATE
11ANDA081214_001RXESTROPIPATE (1.5MG)ORALTABLETFalseAB1993-09-23ESTROPIPATE
12ANDA081215_001RXESTROPIPATE (3MG)ORALTABLETFalseAB1993-09-23ESTROPIPATE
13ANDA081216_001discontinuedESTROPIPATE (6MG)ORALTABLETFalse1993-09-23ESTROPIPATE
14ANDA083220_001RXESTROPIPATE (0.75MG)ORALTABLETFalseABOGEN .625
15ANDA083220_002RXESTROPIPATE (1.5MG)ORALTABLETFalseABOGEN .625
16ANDA083220_003RXESTROPIPATE (3MG)ORALTABLETTrueABOGEN .625
17ANDA083220_004RXESTROPIPATE (6MG)ORALTABLETFalseOGEN .625
18ANDA089567_001discontinuedESTROPIPATE (0.75MG)ORALTABLETFalse1991-02-27ORTHO-EST
19ANDA089582_001discontinuedESTROPIPATE (1.5MG)ORALTABLETFalse1991-07-17ORTHO-EST

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
103cdbf5b-b572-448f-80e9-b3e812959901 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-03-142548683114, 548684149, 548684761
24252d631-03d0-4b37-8a0e-c7dc8fc5438a (view SPL)Estropipate Tablets USPRevised: June2012Rx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2012-07-307005910414, 005910415, 005910416

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