# BRETHINE
> **NDA017849** · New Drug Application · Sponsor: ANI PHARMS · Approved 1976-05-17
## Drug
- **FDA Application Number:** NDA017849
- **Application type:** New Drug Application
- **Brand name:** BRETHINE
- **Generic name:** TERBUTALINE SULFATE
- **Active ingredients:** TERBUTALINE SULFATE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ANI PHARMS
- **Manufacturer:** ANI Pharmaceuticals, Inc.
- **First approval:** 1976-05-17
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017849)
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