Details for New Drug Application (NDA): 020645
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NDA 020645 describes AMMONUL, which is a drug marketed by Bausch and is included in one NDA. It is available from two suppliers. Additional details are available on the AMMONUL profile page.
The generic ingredient in AMMONUL is sodium benzoate; sodium phenylacetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sodium benzoate; sodium phenylacetate profile page.
The generic ingredient in AMMONUL is sodium benzoate; sodium phenylacetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the sodium benzoate; sodium phenylacetate profile page.
Summary for 020645
| Tradename: | AMMONUL |
| Applicant: | Bausch |
| Ingredient: | sodium benzoate; sodium phenylacetate |
| Patents: | 0 |
Pharmacology for NDA: 020645
| Mechanism of Action | Ammonium Ion Binding Activity |
Suppliers and Packaging for NDA: 020645
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMMONUL | sodium benzoate; sodium phenylacetate | SOLUTION;INTRAVENOUS | 020645 | NDA | Bausch Health US LLC | 0187-0010 | 0187-0010-50 | 1 VIAL, SINGLE-USE in 1 CARTON (0187-0010-50) / 50 mL in 1 VIAL, SINGLE-USE |
| AMMONUL | sodium benzoate; sodium phenylacetate | SOLUTION;INTRAVENOUS | 020645 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-001 | 68682-001-50 | 1 VIAL, SINGLE-USE in 1 CARTON (68682-001-50) / 50 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10%;10% (5GM/50ML;5GM/50ML) | ||||
| Approval Date: | Feb 17, 2005 | TE: | RLD: | Yes | |||||
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