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GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2022-08-22
Drug application
- FDA Application #
ANDA216082- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Generic name
- GUAIFENESIN AND PSEUDOEPHEDRINE HCL
- Active ingredients
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Discontinued
- Sponsor
- GRANULES
- Manufacturer
- Granules India Ltd
- First approval
- 2022-08-22
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown