← FDA Drug Approvals (Drugs@FDA)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS USA INC · Approved 2025-11-25
Drug application
- FDA Application #
ANDA217049- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
- Generic name
- Empagliflozin
- Active ingredients
- EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- ZYDUS PHARMS USA INC
- First approval
- 2025-11-25
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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