Details for New Drug Application (NDA): 216462
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NDA 216462 describes SODIUM PHENYLBUTYRATE, which is a drug marketed by Par Pharm, Sigmapharm Labs Llc, Alvogen, and Glenmark Pharms Ltd, and is included in five NDAs. It is available from three suppliers. Additional details are available on the SODIUM PHENYLBUTYRATE profile page.
The generic ingredient in SODIUM PHENYLBUTYRATE is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
The generic ingredient in SODIUM PHENYLBUTYRATE is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
Summary for 216462
| Tradename: | SODIUM PHENYLBUTYRATE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | sodium phenylbutyrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216462
| Mechanism of Action | Ammonium Ion Binding Activity |
Suppliers and Packaging for NDA: 216462
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM PHENYLBUTYRATE | sodium phenylbutyrate | TABLET;ORAL | 216462 | ANDA | GLENMARK PHARMACEUTICALS INC., USA | 68462-853 | 68462-853-20 | 250 TABLET in 1 BOTTLE (68462-853-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Nov 1, 2022 | TE: | AB | RLD: | No | ||||
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