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SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PH HEALTH · Approved 2025-06-04
Drug application
- FDA Application #
ANDA204144
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
- Generic name
- Metformin Hydrochloride
- Active ingredients
- METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- PH HEALTH
- First approval
- 2025-06-04
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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