# FEXOFENADINE HCL; PSEUDOEPHEDRINE HCL
> **ANDA076538** · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN · Approved 2004-04-30
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=076538)
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