Details for New Drug Application (NDA): 203631
NDA 203631 describes SODIUM OXYBATE, which is a drug marketed by Amneal, Ascent Pharms Inc, and Hikma, and is included in three NDAs. It is available from three suppliers. Additional details are available on the SODIUM OXYBATE profile page.
The generic ingredient in SODIUM OXYBATE is sodium oxybate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.
The generic ingredient in SODIUM OXYBATE is sodium oxybate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium oxybate profile page.
Summary for 203631
| Tradename: | SODIUM OXYBATE |
| Applicant: | Amneal |
| Ingredient: | sodium oxybate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203631
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM OXYBATE | sodium oxybate | SOLUTION;ORAL | 203631 | ANDA | Amneal Pharmaceuticals LLC | 65162-065 | 65162-065-87 | 1 BOTTLE in 1 CARTON (65162-065-87) / 180 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 0.5GM/ML | ||||
| Approval Date: | Sep 10, 2025 | TE: | AA | RLD: | No | ||||
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