Clomiphene Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Watson Laboratories, Inc. (2014-03-13)
Oldest Current Product
1967-02-01
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\CLOMIPHENE
FDAOB
ORAL\TABLET\CLOMIPHENE CITRATE
SPL Active
ORAL\TABLET\CLOMIPHENE CITRATE
SPL Moiety
ORAL\TABLET\CLOMIPHENE

product(s) by strength(s)

clomiphene citrate 50 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005910781NDAWatson Laboratories, Inc.1994-09-01CLOMIPHENE CITRATEORALTABLETNDA0161315d544453-f6d4-45a4-9ece-2f705b32011f

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840701ANDAPar Pharmaceutical Companies, Inc.1999-08-30CLOMIPHENE CITRATEORALTABLETANDA075528be399623-6400-475d-93d3-1dedd4d43017

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930041NDA AUTHORIZED GENERICTeva Pharmaceuticals Usa Inc1992-11-01CLOMIPHENE CITRATEORALTABLETNDA018361b2f33ee6-0c57-45d9-b8fc-a8daf2a2185c

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950114ANDARebel Distributors Corp1999-08-30CLOMIPHENE CITRATEORALTABLET498840701ANDA07552849860a2f-92f2-4da8-b78f-0efc005d725a
2430630250NDAPd-Rx Pharmaceuticals, Inc.1967-02-01CLOMIPHENE CITRATEORALTABLET005910781NDA01613153eff40f-37b1-47b1-a9b8-c22360855f18
3548683059ANDAPhysicians Total Care, Inc.1996-08-22CLOMIPHENE CITRATEORALTABLET498840701ANDA075528e9950303-9322-4f27-9e28-f1cedaf87b20

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA072196MILOPHENETrueMILEX PRODUCTS INC1988-12-20ANDA072196_001
2ANDA075528CLOMIPHENE CITRATEPAR PHARMACEUTICAL INC1999-08-30ANDA075528_001
3NDA016131CLOMIDSANOFI AVENTIS US LLCNDA016131_002
4NDA018361SEROPHENETrueEMD SERONO INC1982-03-22NDA018361_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA072196_001discontinuedCLOMIPHENE CITRATE (50MG)ORALTABLETFalse1988-12-20MILOPHENE
2ANDA075528_001RXCLOMIPHENE CITRATE (50MG)ORALTABLETFalseAB1999-08-30CLOMIPHENE CITRATE
3NDA016131_002RXCLOMIPHENE CITRATE (50MG)ORALTABLETTrueABCLOMID
4NDA018361_001discontinuedCLOMIPHENE CITRATE (50MG)ORALTABLETFalse1982-03-22SEROPHENE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
149860a2f-92f2-4da8-b78f-0efc005d725a (view SPL)Clomiphene CitrateprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-231216950114
253eff40f-37b1-47b1-a9b8-c22360855f18 (view SPL)Clomiphene Citrate Tablets USP Revised: June 2004 Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-07-164430630250
35d544453-f6d4-45a4-9ece-2f705b32011f (view SPL)70025264 Clomiphene Citrate Tablets USP Revised: November 2012 Rx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2014-03-136005910781
4b2f33ee6-0c57-45d9-b8fc-a8daf2a2185c (view SPL)ClomiPHENE CITRATE TABLETS, USPprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2012-08-012000930041
5be399623-6400-475d-93d3-1dedd4d43017 (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2013-03-156498840701
6e9950303-9322-4f27-9e28-f1cedaf87b20 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2014-04-102548683059

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