← FDA Drug Approvals (Drugs@FDA)
SODIUM PHENYLBUTYRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SIGMAPHARM LABS LLC · Approved 2013-03-22
Drug application
- FDA Application #
ANDA202819- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SODIUM PHENYLBUTYRATE
- Generic name
- SODIUM PHENYLBUTYRATE
- Active ingredients
- SODIUM PHENYLBUTYRATE
- Dosage form
- POWDER
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SIGMAPHARM LABS LLC
- Manufacturer
- Sigmapharm Laboratories, LLC
- First approval
- 2013-03-22
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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