← FDA Drug Approvals (Drugs@FDA)
LORATADINE AND PSEUDOEPHEDRINE SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM INDS LTD · Approved 2004-09-22
Drug application
- FDA Application #
ANDA076557- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- LORATADINE AND PSEUDOEPHEDRINE SULFATE
- Generic name
- LORATADINE AND PSEUDOEPHEDRINE SULFATE
- Active ingredients
- LORATADINE; PSEUDOEPHEDRINE SULFATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- SUN PHARM INDS LTD
- Manufacturer
- Kirkland-COSTCO WHOLESALE COMPANY
- First approval
- 2004-09-22
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown