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EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LIMITED · Approved 2026-06-11
Drug application
- FDA Application #
ANDA212374- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
- Generic name
- Empagliflozin, Metformin Hydrochloride
- Active ingredients
- EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET
- Route
- —
- Marketing status
- None (Tentative Approval)
- Sponsor
- AUROBINDO PHARMA LIMITED
- First approval
- 2026-06-11
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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