Agenerase
Amprenavir
Sourced from the FDA Orange Book
Key dates
Key dates
Approval
FDA approval date of this drug product.
Apr 15, 1999
27 yr 8 mo ago
Today
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
AMPRENAVIR
Strength
15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 021039
Product number
001
Marketing status
Discontinued
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
View full Amprenavir familyListed patents
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.
Agenerase — frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.
Built directly from the FDA Orange Book data file. This product page links back to the Amprenavir active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
