synthetic conjugated estrogens, A Oral Tablet

Brand(s)
Cenestin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Teva Women'S Health, Inc. (2015-08-18)
Oldest Current Product
1999-05-12
License(s)
NDA
RxNORM
ORAL TABLET\SYNTHETIC CONJUGATED ESTROGENS, A
FDAOB
ORAL\TABLET\ESTROGENS, CONJUGATED SYNTHETIC A
SPL Active
ORAL\TABLET, FILM COATED\ESTROGENS, CONJUGATED SYNTHETIC A
SPL Moiety
ORAL\TABLET, FILM COATED\ESTROGENS, CONJUGATED SYNTHETIC A

product(s) by strength(s)

synthetic conjugated estrogens, a 0.3 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1512850441CenestinNDATeva Women'S Health, Inc.2002-08-052016-04-30ESTROGENS, CONJUGATED SYNTHETIC AORALTABLET, FILM COATEDNDA020992410f9433-98ed-4c3f-abb1-2386296d2f72

synthetic conjugated estrogens, a 0.45 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1512850446CenestinNDATeva Women'S Health, Inc.2004-04-012015-04-30ESTROGENS, CONJUGATED SYNTHETIC AORALTABLET, FILM COATEDNDA020992410f9433-98ed-4c3f-abb1-2386296d2f72

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685415CenestinNDAPhysicians Total Care, Inc.2005-09-13ESTROGENS, CONJUGATED SYNTHETIC AORALTABLET, FILM COATED512850446NDA0209921cd07b54-f66f-4040-9058-462324267196

synthetic conjugated estrogens, a 0.625 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1512850442CenestinNDATeva Women'S Health, Inc.1999-05-122016-04-30ESTROGENS, CONJUGATED SYNTHETIC AORALTABLET, FILM COATEDNDA020992410f9433-98ed-4c3f-abb1-2386296d2f72

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684879CenestinNDAPhysicians Total Care, Inc.2003-08-11ESTROGENS, CONJUGATED SYNTHETIC AORALTABLET, FILM COATED512850442NDA0209921cd07b54-f66f-4040-9058-462324267196

synthetic conjugated estrogens, a 0.9 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1512850443CenestinNDATeva Women'S Health, Inc.1999-05-122016-04-30ESTROGENS, CONJUGATED SYNTHETIC AORALTABLET, FILM COATEDNDA020992410f9433-98ed-4c3f-abb1-2386296d2f72

synthetic conjugated estrogens, a 1.25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1512850444CenestinNDATeva Women'S Health, Inc.2000-03-202016-04-30ESTROGENS, CONJUGATED SYNTHETIC AORALTABLET, FILM COATEDNDA020992410f9433-98ed-4c3f-abb1-2386296d2f72

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548681432CenestinNDAPhysicians Total Care, Inc.2008-03-17ESTROGENS, CONJUGATED SYNTHETIC AORALTABLET, FILM COATED512850444NDA0209921cd07b54-f66f-4040-9058-462324267196

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA020992CENESTINTEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC1999-03-24p5908638, SUBSTANCENDA020992_001, NDA020992_002, NDA020992_003, NDA020992_004, NDA020992_005

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020992_001RXESTROGENS, CONJUGATED SYNTHETIC A (0.3MG)ORALTABLETFalse2002-06-21CENESTIN
2NDA020992_002RXESTROGENS, CONJUGATED SYNTHETIC A (0.625MG)ORALTABLETFalse1999-03-24CENESTIN
3NDA020992_003RXESTROGENS, CONJUGATED SYNTHETIC A (0.9MG)ORALTABLETFalse1999-03-24CENESTIN
4NDA020992_004RXESTROGENS, CONJUGATED SYNTHETIC A (1.25MG)ORALTABLETTrue2000-03-13CENESTIN
5NDA020992_005RXESTROGENS, CONJUGATED SYNTHETIC A (0.45MG)ORALTABLETFalse2004-02-05CENESTIN

patent(s)

#idexpiration dateapplication(s)
1p5908638 (view patent)2015-07-26NDA020992

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11cd07b54-f66f-4040-9058-462324267196 (view SPL)Cenestin (synthetic conjugated estrogens, A) TabletsprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2004-09-011548681432, 548684879, 548685415
2410f9433-98ed-4c3f-abb1-2386296d2f72 (view SPL)These highlights do not include all the information needed to use CENESTIN safely and effectively. See full prescribing information for CENESTIN. CENESTIN (synthetic conjugated estrogens, A) Tablets for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionTeva Women'S Health, Inc.2015-08-185512850441, 512850442, 512850443, 512850444, 512850446

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