# AZITHROMYCIN
> **ANDA065501** · Abbreviated New Drug Application (Generic) · Sponsor: GLAND PHARMA LTD · Approved 2009-11-09
## Drug
- **FDA Application Number:** ANDA065501
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** AZITHROMYCIN
- **Generic name:** AZITHROMYCIN MONOHYDRATE
- **Active ingredients:** AZITHROMYCIN
- **Dosage form:** INJECTABLE
- **Route:** INJECTION
- **Marketing status:** Prescription
- **Sponsor:** GLAND PHARMA LTD
- **Manufacturer:** Gland Pharma Limited
- **First approval:** 2009-11-09
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=065501)
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