Details for New Drug Application (NDA): 219750
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NDA 219750 describes L-GLUTAMINE, which is a drug marketed by Annora Pharma, Novitium Pharma, and Renova Pharms, and is included in three NDAs. It is available from three suppliers. Additional details are available on the L-GLUTAMINE profile page.
The generic ingredient in L-GLUTAMINE is l-glutamine. There are forty-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the l-glutamine profile page.
The generic ingredient in L-GLUTAMINE is l-glutamine. There are forty-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the l-glutamine profile page.
Summary for 219750
| Tradename: | L-GLUTAMINE |
| Applicant: | Renova Pharms |
| Ingredient: | l-glutamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219750
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| L-GLUTAMINE | l-glutamine | FOR SOLUTION;ORAL | 219750 | ANDA | Renova Pharmaceuticals LLC | 84897-057 | 84897-057-60 | 60 PACKET in 1 CARTON (84897-057-60) / 1 POWDER, FOR SOLUTION in 1 PACKET (84897-057-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 5GM/PACKET | ||||
| Approval Date: | May 14, 2026 | TE: | AA | RLD: | No | ||||
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