FDA Orange Book · active-ingredient family
L-glutamine
L-glutamine is approved as 2 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ENDARI · NDA 208587
2
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ENDARIRLD | EMMAUS MEDCL | NDA 208587 | AA | Jul 07, 2017 | |
| NUTRESTORERLD | EMMAUS MEDCL | NDA 021667 | — | Jun 10, 2004 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| L-GLUTAMINE | ANNORA PHARMA | ANDA 219722 | AA | May 26, 2026 | |
| L-GLUTAMINE | RENOVA PHARMS | ANDA 219750 | AA | May 14, 2026 | |
| L-GLUTAMINE | NOVITIUM PHARMA | ANDA 215647 | AA | Jul 08, 2024 |
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.
L-glutamine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
