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NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2020-09-24
Drug application
- FDA Application #
ANDA213663- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
- Generic name
- NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL
- Active ingredients
- DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- GRANULES
- Manufacturer
- Granules India Ltd
- First approval
- 2020-09-24
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown