FDA.reportPublic FDA data

Application 021417

Type
NDA
Sponsor
WYETH PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREMARINESTROGENS, CONJUGATEDTABLET; ORAL0.3MGNoNo
002PREMARINESTROGENS, CONJUGATEDTABLET; ORAL0.45MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PremarinESTROGENS, CONJUGATEDWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.258e1602-a3cf-4ccc-ca80-73dbbfb812ff2026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Premarin
generic name: ESTROGENS, CONJUGATED
Conjugated EstrogensESTROGENS, CONJUGATEDPrasco Laboratoriesce793f9e-0c20-43e6-9dc0-064e5c82e2432026-02-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTROGENS, CONJUGATED
estrogens, conjugatedESTROGENS, CONJUGATEDIngenus Pharmaceuticals, LLC7277bab4-d8c2-4e4b-a0d9-5dfe1885d5472025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTROGENS, CONJUGATED
estrogens, conjugatedESTROGENS, CONJUGATEDIngenus Pharmaceuticals, LLCb17eca23-f387-4243-a76a-bcf6b88aeef92025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ESTROGENS, CONJUGATED
PremarinCONJUGATED ESTROGENSWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.87e2da8d-432c-4ed5-67a1-dc26294b22952025-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Premarin
PremarinESTROGENS, CONJUGATEDA-S Medication Solutionsa3b86b85-8923-42ae-aa31-a66a6e0903272025-04-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Premarin
generic name: ESTROGENS, CONJUGATED
PREMARINESTROGENS, CONJUGATEDA-S Medication Solutions2b4dbb7c-4e6d-47c9-b940-fef91f1f4a052024-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PREMARIN
generic name: ESTROGENS, CONJUGATED

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
36867ORIG2004-06-14
21644ORIG2003-09-25
27725ORIG2003-07-28