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GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS · Approved 2023-08-01
Drug application
- FDA Application #
ANDA217340- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
- Generic name
- GUAIFENESIN AND DEXTROMETHORPHAN HBR
- Active ingredients
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- DR REDDYS
- Manufacturer
- CVS Pharmacy
- First approval
- 2023-08-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown