FDA Orange Book · active-ingredient family
Fosinopril sodium
Fosinopril sodium: 1 brand, 11 generics; first approved May 16, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
11
Listed patents
0
Presentations
36
Brand (NDA) products
Originator applications
- MONOPRILRLDBRISTOL MYERS SQUIBBNDA 01991519913 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued —
Generic (ANDA) products (11)
Abbreviated applications
- FOSINOPRIL SODIUMPRINSTON INCANDA 20567020163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FOSINOPRIL SODIUMAUROBINDO PHARMA LTDANDA 09116320113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FOSINOPRIL SODIUMWATSON LABSANDA 07753120063 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - FOSINOPRIL SODIUMAPOTEXANDA 07690620053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - FOSINOPRIL SODIUMINVAGEN PHARMSANDA 07722220053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FOSINOPRIL SODIUMWATSON LABSANDA 07698720043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - FOSINOPRIL SODIUMACTAVIS LABS FL INCANDA 07662020043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - FOSINOPRIL SODIUMUPSHER SMITH LABSANDA 07618820043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - FOSINOPRIL SODIUMCHARTWELL RXANDA 07648320043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB - FOSINOPRIL SODIUMRANBAXY LABS LTDANDA 07658020043 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Discontinued — 20MG TABLET ORAL Discontinued — 40MG TABLET ORAL Discontinued — - FOSINOPRIL SODIUMTEVAANDA 07613920033 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 20MG TABLET ORAL Rx AB 40MG TABLET ORAL Rx AB
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
35 yr 11 mo ago
Most recent approval
10 yr 3 mo ago
Approvals span 1991–2016 across 12 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1192%
Fosinopril sodium: 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.
