# CLARITIN
> **NDA019658** · New Drug Application · Sponsor: BAYER HEALTHCARE LLC · Approved 1993-04-12
## Drug
- **FDA Application Number:** NDA019658
- **Application type:** New Drug Application
- **Brand name:** CLARITIN
- **Generic name:** LORATADINE
- **Active ingredients:** LORATADINE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** BAYER HEALTHCARE LLC
- **Manufacturer:** Bayer HealthCare LLC
- **First approval:** 1993-04-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=019658)
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