← FDA Drug Approvals (Drugs@FDA)
IRBESARTAN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MACLEODS PHARMS LTD · Approved 2012-10-03
Drug application
- FDA Application #
ANDA202254- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- IRBESARTAN
- Generic name
- IRBESARTAN
- Active ingredients
- IRBESARTAN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- MACLEODS PHARMS LTD
- Manufacturer
- NorthStar RxLLC
- First approval
- 2012-10-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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