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PROMETHAZINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: STRIDES PHARMA · Approved 2009-03-13
Drug application
- FDA Application #
ANDA040891- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- PROMETHAZINE HYDROCHLORIDE
- Generic name
- PROMETHAZINE HYDROCHLORIDE
- Active ingredients
- PROMETHAZINE HYDROCHLORIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- STRIDES PHARMA
- Manufacturer
- Nostrum Laboratories, Inc.
- First approval
- 2009-03-13
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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