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Details for New Drug Application (NDA): 204395
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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. Two 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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