Home Applications 202425 Application 202425
Type ANDA
Sponsor APOTEX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SITAGLIPTIN PHOSPHATE SITAGLIPTIN PHOSPHATE TABLET; ORAL 25MG No No 002 SITAGLIPTIN PHOSPHATE SITAGLIPTIN PHOSPHATE TABLET; ORAL 50MG No No 003 SITAGLIPTIN PHOSPHATE SITAGLIPTIN PHOSPHATE TABLET; ORAL 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202425-001 SITAGLIPTIN PHOSPHATE SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2026-01-20 A202425-002 SITAGLIPTIN PHOSPHATE SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2026-01-20 A202425-003 SITAGLIPTIN PHOSPHATE SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2026-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration A202425-001 PC 2026-11-24 A202425-002 PC 2026-11-24 A202425-003 PC 2026-11-24
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A202425-001 SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2026-01-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202425-002 SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2026-01-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202425-003 SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2026-01-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202425-001 SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2026-01-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202425-002 SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2026-01-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202425-003 SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2026-01-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202425-001 SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2026-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202425-002 SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2026-01-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202425-003 SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2026-01-20 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202425-001 SITAGLIPTIN PHOSPHATE EQ 25MG BASE TABLET / ORAL AB 2026-01-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202425-002 SITAGLIPTIN PHOSPHATE EQ 50MG BASE TABLET / ORAL AB 2026-01-20 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202425-003 SITAGLIPTIN PHOSPHATE EQ 100MG BASE TABLET / ORAL AB 2026-01-20 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sitagliptin SITAGLIPTIN Golden State Medical Supply, Inc. 58e23b30-451c-f451-e063-6394a90a35a7 2026-08-12 Warnings, Adverse reactions Exact identifier application applno (ANDA): 202425 application number: ANDA202425
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.