← FDA Drug Approvals (Drugs@FDA)
PROMETHEGAN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: COSETTE · Approved 1987-08-14
Drug application
- FDA Application #
ANDA087165- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHEGAN
- Generic name
- PROMETHAZINE HYDROCHLORIDE
- Active ingredients
- PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SUPPOSITORY
- Route
- RECTAL
- Marketing status
- Prescription
- Sponsor
- COSETTE
- Manufacturer
- Cosette Pharmaceuticals, Inc.
- First approval
- 1987-08-14
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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