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PROMETHAZINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PADAGIS ISRAEL · Approved 2003-06-30
Drug application
- FDA Application #
ANDA040500- 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
- PADAGIS ISRAEL
- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- First approval
- 2003-06-30
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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