Ascorbic acid
Ascorbic acid: 1 brand, 3 generics; first approved Oct 02, 2017; generic available.
Generic available: 3 ANDA applications approved.
Brand (NDA) products
- MCGUFFNDA 2091122017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25,000MG/50ML (500MG/ML) SOLUTION INTRAVENOUS Rx AP
Generic (ANDA) products (3)
- ASCORBIC ACIDRSZYDUS PHARMSANDA 22087320263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2,500MG/5ML (500MG/ML) SOLUTION INTRAVENOUS Rx - 5,000MG/10ML (500MG/ML) SOLUTION INTRAVENOUS Rx - 25,000MG/50ML (500MG/ML) SOLUTION INTRAVENOUS Rx AP - ASCORBIC ACIDSTIRAANDA 2201722026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25,000MG/50ML (500MG/ML) SOLUTION INTRAVENOUS Rx AP - ASCORBIC ACIDFRESENIUS KABI USAANDA 2171312025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25,000MG/50ML (500MG/ML) SOLUTION INTRAVENOUS Rx AP
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 2017–2026 across 4 FDA applications.
Ascorbic acid: 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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