Details for New Drug Application (NDA): 215025
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The generic ingredient in SODIUM PHENYLACETATE AND SODIUM BENZOATE 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 215025
Tradename: | SODIUM PHENYLACETATE AND SODIUM BENZOATE |
Applicant: | Maia Pharms Inc |
Ingredient: | sodium benzoate; sodium phenylacetate |
Patents: | 0 |
Pharmacology for NDA: 215025
Mechanism of Action | Ammonium Ion Binding Activity |
Suppliers and Packaging for NDA: 215025
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SODIUM PHENYLACETATE AND SODIUM BENZOATE | sodium benzoate; sodium phenylacetate | SOLUTION;INTRAVENOUS | 215025 | NDA | MAIA PHARMACEUTICALS | 70511-102 | 70511-102-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70511-102-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
SODIUM PHENYLACETATE AND SODIUM BENZOATE | sodium benzoate; sodium phenylacetate | SOLUTION;INTRAVENOUS | 215025 | NDA | FOSUN PHARMA USA INC | 72266-236 | 72266-236-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (72266-236-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 10%;10% (2GM/20ML;2GM/20ML) | ||||
Approval Date: | Jun 10, 2021 | TE: | AP | RLD: | Yes |
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