Gadoversetamide
Gadoversetamide: 3 brands, 0 generics; first approved Dec 08, 1999.
No listed patents or exclusivity: brand product(s) only.
Brand (NDA) products
- OPTIMARKRLDLIEBEL-FLARSHEIMNDA 0209751999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 16.545GM/50ML (330.9MG/ML) INJECTABLE INJECTION Discontinued - - OPTIMARKRLDLIEBEL-FLARSHEIMNDA 02093719994 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1654.5MG/5ML (330.9MG/ML) INJECTABLE INJECTION Discontinued - 3309MG/10ML (330.9MG/ML) INJECTABLE INJECTION Discontinued - 4963.5MG/15ML (330.9MG/ML) INJECTABLE INJECTION Discontinued - 6618MG/20ML (330.9MG/ML) INJECTABLE INJECTION Discontinued - - LIEBEL-FLARSHEIMNDA 02097619994 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 9927MG/30ML (330.9MG/ML) INJECTABLE INJECTION Discontinued - 3309MG/10ML (330.9MG/ML) INJECTABLE INJECTION Discontinued - 4963.5MG/15ML (330.9MG/ML) INJECTABLE INJECTION Discontinued - 6618MG/20ML (330.9MG/ML) INJECTABLE INJECTION 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
All 3 applications were approved in 1999.
Gadoversetamide: 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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