FDA Orange Book · active-ingredient family
Flumazenil
Flumazenil: 1 brand, 9 generics; first approved Dec 20, 1991; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
9
Listed patents
0
Presentations
20
Brand (NDA) products
Originator applications
- ROMAZICONRLDHOFFMANN LA ROCHENDA 02007319912 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Discontinued — 0.5MG/5ML (0.1MG/ML) INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (9)
Abbreviated applications
- FLUMAZENILSAGENT PHARMSANDA 09058420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/5ML (0.1MG/ML) INJECTABLE INJECTION Rx AP 1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Rx AP - FLUMAZENILHIKMA FARMACEUTICAANDA 07852720092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/5ML (0.1MG/ML) INJECTABLE INJECTION Rx AP 1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Rx AP - FLUMAZENILRISINGANDA 07859520082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/5ML (0.1MG/ML) INJECTABLE INJECTION Rx AP 1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Discontinued — - FLUMAZENILSANDOZANDA 07707120052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG/5ML (0.1MG/ML) INJECTABLE INJECTION Rx AP 1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Rx AP - FLUMAZENILBAXTER HLTHCARE CORPANDA 07675520042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Rx AP 0.5MG/5ML (0.1MG/ML) INJECTABLE INJECTION Rx AP - FLUMAZENILDR REDDYSANDA 07658920042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Discontinued — 0.5MG/5ML (0.1MG/ML) INJECTABLE INJECTION Discontinued — - FLUMAZENILFRESENIUS KABI USAANDA 07695520042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Rx AP 0.5MG/5ML (0.1MG/ML) INJECTABLE INJECTION Rx AP - FLUMAZENILHIKMAANDA 07625620042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Rx AP 0.5MG/5ML (0.1MG/ML) INJECTABLE INJECTION Rx AP - FLUMAZENILHIKMAANDA 07678720042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Discontinued — 0.5MG/5ML (0.1MG/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
35 yr 4 mo ago
Most recent approval
14 yr 4 mo ago
Approvals span 1991–2012 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Flumazenil: 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.
