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SODIUM PHENYLACETATE AND SODIUM BENZOATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NAVINTA LLC · Approved 2016-08-04
Drug application
- FDA Application #
ANDA205880
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SODIUM PHENYLACETATE AND SODIUM BENZOATE
- Generic name
- SODIUM PHENYLACETATE AND SODIUM BENZOATE
- Active ingredients
- SODIUM BENZOATE; SODIUM PHENYLACETATE
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing status
- Prescription
- Sponsor
- NAVINTA LLC
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- First approval
- 2016-08-04
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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