← FDA Drug Approvals (Drugs@FDA)
GLYCEROL PHENYLBUTYRATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANNORA PHARMA · Approved 2022-08-09
Drug application
- FDA Application #
ANDA215139- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- GLYCEROL PHENYLBUTYRATE
- Generic name
- Glycerol Phenylbutyrate
- Active ingredients
- GLYCEROL PHENYLBUTYRATE
- Dosage form
- LIQUID
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- ANNORA PHARMA
- First approval
- 2022-08-09
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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