← FDA Drug Approvals (Drugs@FDA)
ITRACONAZOLE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2017-06-12
Drug application
- FDA Application #
ANDA208591- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ITRACONAZOLE
- Generic name
- ITRACONAZOLE
- Active ingredients
- ITRACONAZOLE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALKEM LABS LTD
- Manufacturer
- Ascend Laboratories, LLC
- First approval
- 2017-06-12
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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