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FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: WOCKHARDT · Approved 2010-10-19
Drug application
- FDA Application #
ANDA079115- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Generic name
- Fexofenadine Hydrochloride
- Active ingredients
- FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- WOCKHARDT
- First approval
- 2010-10-19
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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