Details for New Drug Application (NDA): 202819
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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. Six suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.
Summary for 202819
Tradename: | SODIUM PHENYLBUTYRATE |
Applicant: | Sigmapharm Labs Llc |
Ingredient: | sodium phenylbutyrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202819
Mechanism of Action | Ammonium Ion Binding Activity |
Suppliers and Packaging for NDA: 202819
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SODIUM PHENYLBUTYRATE | sodium phenylbutyrate | POWDER;ORAL | 202819 | ANDA | Sigmapharm Laboratories, LLC | 42794-086 | 42794-086-14 | 1 BOTTLE in 1 CARTON (42794-086-14) / 250 g in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;ORAL | Strength | 3GM/TEASPOONFUL | ||||
Approval Date: | Mar 22, 2013 | TE: | AB | RLD: | No |
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