← FDA Drug Approvals (Drugs@FDA)
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2021-07-01
Drug application
- FDA Application #
ANDA214781- 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
- SUN PHARM
- Manufacturer
- OHM LABORATORIES INC
- First approval
- 2021-07-01
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown