# TERBUTALINE SULFATE
> **ANDA078630** · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA FARMACEUTICA · Approved 2009-05-20
## Drug
- **FDA Application Number:** ANDA078630
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** TERBUTALINE SULFATE
- **Generic name:** TERBUTALINE SULFATE
- **Active ingredients:** TERBUTALINE SULFATE
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** HIKMA FARMACEUTICA
- **Manufacturer:** Hikma Pharmaceuticals USA Inc.
- **First approval:** 2009-05-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=078630)
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