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FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: DR REDDYS LABS LTD · Approved 2010-03-17
Drug application
- FDA Application #
ANDA079043- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
- Generic name
- FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI
- Active ingredients
- FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Over-the-counter
- Sponsor
- DR REDDYS LABS LTD
- Manufacturer
- Dr.Reddy's Laboratories Limited
- First approval
- 2010-03-17
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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