FDA Orange Book · active-ingredient family
Estrogens, conjugated synthetic b
Estrogens, conjugated synthetic b: 1 brand, 0 generics; first approved May 10, 2004.
Brand onlyHas discontinued products
Generic status & protection
No listed patents or exclusivity: brand product(s) only.
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
5
Brand (NDA) products
Originator applications
- ASPENNDA 02144320045 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.3MG TABLET ORAL Discontinued — 0.45MG TABLET ORAL Discontinued — 0.625MG TABLET ORAL Discontinued — 1.25MG TABLET ORAL Discontinued — 0.9MG 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.
Approval history
FDA approval span
First approval
22 yr 6 mo ago
Most recent approval
19 yr 6 mo ago
Approvals span 2004–2007 across 1 FDA application.
Brand (NDA) 1100%
Generic (ANDA) 00%
Estrogens, conjugated synthetic b: 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
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
