← FDA Drug Approvals (Drugs@FDA)
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM INDS INC · Approved 2020-04-28
Drug application
- FDA Application #
ANDA212542- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Generic name
- GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Active ingredients
- GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- SUN PHARM INDS INC
- Manufacturer
- RUGBY LABORATORIES, INC.
- First approval
- 2020-04-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown