# LORATADINE AND PSEUDOEPHEDRINE SULFATE
> **ANDA076050** · Abbreviated New Drug Application (Generic) · Sponsor: PERRIGO PHARMA INTL · Approved 2003-01-30
## Drug
- **FDA Application Number:** ANDA076050
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** LORATADINE AND PSEUDOEPHEDRINE SULFATE
- **Generic name:** LORATADINE, PSEUDOEPHEDRINE SULFATE
- **Active ingredients:** LORATADINE; PSEUDOEPHEDRINE SULFATE
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** PERRIGO PHARMA INTL
- **Manufacturer:** L. Perrigo Company
- **First approval:** 2003-01-30
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=076050)
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