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Details for New Drug Application (NDA): 204395
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NDA 204395 describes SODIUM PHENYLBUTYRATE, which is a drug marketed by Par Pharm, Sigmapharm Labs Llc, and Alvogen Malta, and is included in four NDAs. It is available from two 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. Three 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. Three suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
Summary for 204395
| Tradename: | SODIUM PHENYLBUTYRATE |
| Applicant: | Par Pharm |
| Ingredient: | sodium phenylbutyrate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204395
| Mechanism of Action | Ammonium Ion Binding Activity |
Suppliers and Packaging for NDA: 204395
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM PHENYLBUTYRATE | sodium phenylbutyrate | TABLET;ORAL | 204395 | ANDA | Par Pharmaceutical, Inc. | 49884-170 | 49884-170-04 | 1 BOTTLE in 1 CARTON (49884-170-04) > 250 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Apr 15, 2016 | TE: | AB | RLD: | No | ||||
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