← FDA Drug Approvals (Drugs@FDA)
FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 2004-04-30
Drug application
- FDA Application #
ANDA076538- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL
- Generic name
- Fexofenadine Hydrochloride
- Active ingredients
- FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- MYLAN
- First approval
- 2004-04-30
Source
- Authoritative
- Drugs@FDA application overview
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