FDA Orange Book · active-ingredient family
Estropipate
Estropipate: 0 brands, 11 generics; first approved Feb 27, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Brands (NDA)
0
Generics (ANDA)
11
Listed patents
0
Presentations
20
Generic (ANDA) products (11)
Abbreviated applications
- ESTROPIPATEDURAMED PHARMS BARRANDA 04029619993 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued — 1.5MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — - ESTROPIPATEPHARMOBEDIENTANDA 04035919993 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued — 1.5MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — - ESTROPIPATEBARRANDA 04013519963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued — 1.5MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — - ESTROPIPATEWATSON LABSANDA 0812131993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued — - ESTROPIPATEWATSON LABSANDA 0812141993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL Discontinued — - ESTROPIPATEWATSON LABSANDA 0812161993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 6MG TABLET ORAL Discontinued — - ESTROPIPATEWATSON LABS TEVAANDA 0812151993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3MG TABLET ORAL Discontinued — - SUN PHARM INDS INCANDA 0895821991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG TABLET ORAL Discontinued — - SUN PHARM INDS INCANDA 0895671991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued — - PHARMACIA AND UPJOHNANDA 084710—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.5MG/GM CREAM VAGINAL Discontinued — - OGEN .625RLDPFIZERANDA 083220—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.75MG TABLET ORAL Discontinued — 1.5MG TABLET ORAL Discontinued — 3MG TABLET ORAL Discontinued — 6MG TABLET ORAL Rx —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
36 yr ago
Most recent approval
27 yr 2 mo ago
Approvals span 1991–1999 across 11 FDA applications.
Brand (NDA) 00%
Generic (ANDA) 11100%
Estropipate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
