← FDA Drug Approvals (Drugs@FDA)
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2020-03-25
Drug application
- FDA Application #
ANDA213203- 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
- Over-the-counter
- Sponsor
- AUROBINDO PHARMA LTD
- Manufacturer
- Amerisource Bergen
- First approval
- 2020-03-25
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown