← FDA Drug Approvals (Drugs@FDA)
AZITHROMYCIN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLAND PHARMA LTD · Approved 2009-11-09
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
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