Details for New Drug Application (NDA): 215647
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NDA 215647 describes L-GLUTAMINE, which is a drug marketed by Novitium Pharma and is included in one NDA. It is available from one supplier. 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. Two 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. Two suppliers are listed for this compound. Additional details are available on the l-glutamine profile page.
Summary for 215647
| Tradename: | L-GLUTAMINE |
| Applicant: | Novitium Pharma |
| Ingredient: | l-glutamine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215647
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| L-GLUTAMINE | l-glutamine | FOR SOLUTION;ORAL | 215647 | ANDA | ANI Pharmaceuticals, Inc. | 70954-417 | 70954-417-20 | 60 PACKET in 1 CARTON (70954-417-20) / 1 POWDER, FOR SOLUTION in 1 PACKET (70954-417-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 5GM/PACKET | ||||
| Approval Date: | Jul 8, 2024 | TE: | AA | RLD: | No | ||||
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