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NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS LABS INC · Approved 2006-09-27
Drug application
- FDA Application #
ANDA077381- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Generic name
- Naproxen Sodium
- Active ingredients
- NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- DR REDDYS LABS INC
- First approval
- 2006-09-27
Source
- Authoritative
- Drugs@FDA application overview
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