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NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2022-06-01
Drug application
- FDA Application #
ANDA211360- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Generic name
- NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Active ingredients
- NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- AUROBINDO PHARMA
- Manufacturer
- VESPYR BRANDS LLC
- First approval
- 2022-06-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown