Details for New Drug Application (NDA): 210523
NDA 210523 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 210523
| Tradename: | SODIUM OXYBATE |
| Applicant: | Ascent Pharms Inc |
| Ingredient: | sodium oxybate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 210523
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM OXYBATE | sodium oxybate | SOLUTION;ORAL | 210523 | ANDA | Camber Pharmaceuticals, Inc. | 31722-891 | 31722-891-18 | 1 BOTTLE in 1 CARTON (31722-891-18) / 180 mL in 1 BOTTLE |
| SODIUM OXYBATE | sodium oxybate | SOLUTION;ORAL | 210523 | ANDA | XLCare Pharmaceuticals, Inc. | 72865-349 | 72865-349-18 | 1 BOTTLE in 1 CARTON (72865-349-18) / 180 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 0.5GM/ML | ||||
| Approval Date: | Nov 5, 2025 | TE: | AA | RLD: | No | ||||
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