FDA Orange Book · active-ingredient family
Diethylstilbestrol
Diethylstilbestrol: 4 brands, 6 generics; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
6
Listed patents
0
Presentations
32
Brand (NDA) products
Originator applications
- BRISTOL MYERS SQUIBBNDA 004056—15 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG SUPPOSITORY VAGINAL Discontinued — 0.5MG SUPPOSITORY VAGINAL Discontinued — 0.2MG/ML INJECTABLE INJECTION Discontinued — 0.5MG/ML INJECTABLE INJECTION Discontinued — 1MG/ML INJECTABLE INJECTION Discontinued — 5MG/ML INJECTABLE INJECTION Discontinued — 0.1MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 0.1MG TABLET, DELAYED RELEASE ORAL Discontinued — 0.5MG TABLET, DELAYED RELEASE ORAL Discontinued — 1MG TABLET, DELAYED RELEASE ORAL Discontinued — 5MG TABLET, DELAYED RELEASE ORAL Discontinued — 0.25MG TABLET ORAL Discontinued — - DIETHYLSTILBESTROLLILLYNDA 004040—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG SUPPOSITORY VAGINAL Discontinued — 0.5MG SUPPOSITORY VAGINAL Discontinued — - DIETHYLSTILBESTROLLILLYNDA 004039—5 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET, DELAYED RELEASE ORAL Discontinued — 0.5MG TABLET, DELAYED RELEASE ORAL Discontinued — 1MG TABLET, DELAYED RELEASE ORAL Discontinued — 0.25MG TABLET, DELAYED RELEASE ORAL Discontinued — 5MG TABLET, DELAYED RELEASE ORAL Discontinued — - DIETHYLSTILBESTROLLILLYNDA 004041—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- TABLICAPSANDA 083003—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET, DELAYED RELEASE ORAL Discontinued — - TABLICAPSANDA 083005—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET, DELAYED RELEASE ORAL Discontinued — - TABLICAPSANDA 083007—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, DELAYED RELEASE ORAL Discontinued — - TABLICAPSANDA 083004—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — - TABLICAPSANDA 083002—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - TABLICAPSANDA 083006—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL 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.
Diethylstilbestrol: 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.
