← FDA Drug Approvals (Drugs@FDA)
PROMETHAZINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ANNORA PHARMA · Approved 2022-11-02
Drug application
- FDA Application #
ANDA216446- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHAZINE HYDROCHLORIDE
- Generic name
- PROMETHAZINE HYDROCHLORIDE
- Active ingredients
- PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Marketing status
- Prescription
- Sponsor
- ANNORA PHARMA
- Manufacturer
- Camber Pharmaceuticals, Inc.
- First approval
- 2022-11-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown