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FDA ANDA · ANDA202327

SITAGLIPTIN

Sponsor: WATSON LABS INC

APPLICATION
ANDA202327
TYPE
ANDA
ORIGINAL APPROVAL
2025-12-29
LATEST ACTION
2025-12-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SITAGLIPTIN PHOSPHATEPrescription
SITAGLIPTIN PHOSPHATE EQ 50MG BASE · TABLET · ORAL
SITAGLIPTIN PHOSPHATEPrescription
SITAGLIPTIN PHOSPHATE EQ 100MG BASE · TABLET · ORAL
SITAGLIPTIN PHOSPHATEPrescription
SITAGLIPTIN PHOSPHATE EQ 25MG BASE · TABLET · ORAL

Approval history

2025-12-29Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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