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ONDANSETRON HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLAND PHARMA LTD · Approved 2009-09-25
Drug application
- FDA Application #
ANDA079224- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ONDANSETRON HYDROCHLORIDE
- Generic name
- ONDANSETRON
- Active ingredients
- ONDANSETRON HYDROCHLORIDE
- Dosage form
- INJECTABLE
- Route
- INJECTION
- Marketing status
- Prescription
- Sponsor
- GLAND PHARMA LTD
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- First approval
- 2009-09-25
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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