Metaraminol bitartrate
Metaraminol bitartrate: 1 brand, 5 generics; first approved Dec 22, 1987; generic available.
Generic available: 5 ANDA applications approved.
Brand (NDA) products
- ARAMINERLDMERCKNDA 0095091987
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued -
Generic (ANDA) products (5)
- METARAMINOL BITARTRATEAZURITYANDA 2113042021
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Rx - - METARAMINOL BITARTRATEABRAXIS PHARMANDA 080431-
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued - - METARAMINOL BITARTRATEELKINS SINNANDA 083363-
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued - - METARAMINOL BITARTRATEFRESENIUS KABI USAANDA 080722-
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued - - METARAMINOL BITARTRATEGD SEARLE LLCANDA 086418-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/ML INJECTABLE INJECTION Discontinued - EQ 20MG BASE/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
Approvals span 1987–2021 across 6 FDA applications.
Metaraminol bitartrate: 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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