← FDA Drug Approvals (Drugs@FDA)
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM INDS LTD · Approved 2012-09-28
Drug application
- FDA Application #
ANDA090922- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Generic name
- CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Active ingredients
- CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- SUN PHARM INDS LTD
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- First approval
- 2012-09-28
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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