Prazepam
Prazepam: 2 brands, 2 generics; first approved May 10, 1982; generic available.
Generic available: 2 ANDA applications approved.
Brand (NDA) products
- PARKE DAVISNDA 018144-3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued - 10MG CAPSULE ORAL Discontinued - 20MG CAPSULE ORAL Discontinued - - PARKE DAVISNDA 017415-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued -
Generic (ANDA) products (2)
- PRAZEPAMUSL PHARMAANDA 0704271987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL Discontinued - - PRAZEPAMUSL PHARMAANDA 0704281987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued -
Listed patents
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
Approvals span 1982–1987 across 4 FDA applications.
Prazepam: 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.
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