Details for New Drug Application (NDA): 210523
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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 one supplier. Additional details are available on the SODIUM OXYBATE profile page.
The generic ingredient in SODIUM OXYBATE is sodium oxybate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Five 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 are one thousand four hundred and seventy-two drug master file entries for this compound. Five 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 |
Medical Subject Heading (MeSH) Categories for 210523
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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