FDA Orange Book · active-ingredient family
Dienestrol
Dienestrol: 1 brand, 3 generics; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
3
Listed patents
0
Presentations
4
Brand (NDA) products
Originator applications
- DIENESTROLORTHO MCNEIL PHARMNDA 006110—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.01% CREAM VAGINAL Discontinued —
Generic (ANDA) products (3)
Abbreviated applications
- SANOFI AVENTIS USANDA 083518—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.01% CREAM VAGINAL Discontinued — - SOLVAYANDA 084436—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.01% CREAM VAGINAL Discontinued — - SANOFI AVENTIS USANDA 083517—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.7MG SUPPOSITORY VAGINAL Discontinued —
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.
Dienestrol: 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.
