FDA Orange Book · active-ingredient family
Enalaprilat
Enalaprilat: 1 brand, 6 generics; first approved Feb 09, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
7
Brand (NDA) products
Originator applications
- VASOTECRLDBIOVAIL LABS INTLNDA 0193091988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.25MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- ENALAPRILATRSHIKMA FARMACEUTICAANDA 0786872008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.25MG/ML INJECTABLE INJECTION Rx AP - ENALAPRILATCHARTWELL INJECTABLEANDA 0756342000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.25MG/ML INJECTABLE INJECTION Rx AP - ENALAPRILATDR REDDYSANDA 0755782000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.25MG/ML INJECTABLE INJECTION Rx AP - ENALAPRILATHOSPIRAANDA 0754562000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.25MG/ML INJECTABLE INJECTION Discontinued — - ENALAPRILATHOSPIRAANDA 0754582000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.25MG/ML INJECTABLE INJECTION Discontinued — - ENALAPRILATHOSPIRAANDA 0755712000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.25MG/ML INJECTABLE INJECTION 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
39 yr 1 mo ago
Most recent approval
17 yr 11 mo ago
Approvals span 1988–2008 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Enalaprilat: 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.
