L-glutamine
L-glutamine: 2 brands, 3 generics; first approved Jun 10, 2004; generic available.
Generic available: 3 ANDA applications approved.
Brand (NDA) products
- ENDARIRLDEMMAUS MEDCLNDA 2085872017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/PACKET FOR SOLUTION ORAL Rx AA - NUTRESTORERLDEMMAUS MEDCLNDA 0216672004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/PACKET FOR SOLUTION ORAL Discontinued -
Generic (ANDA) products (3)
- L-GLUTAMINEANNORA PHARMAANDA 2197222026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/PACKET FOR SOLUTION ORAL Rx AA - L-GLUTAMINERENOVA PHARMSANDA 2197502026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/PACKET FOR SOLUTION ORAL Rx AA - L-GLUTAMINENOVITIUM PHARMAANDA 2156472024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5GM/PACKET FOR SOLUTION ORAL Rx AA
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 2004–2026 across 5 FDA applications.
L-glutamine: 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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