FDA.reportPublic FDA data

Application 204144

Type
ANDA
Sponsor
ANCHEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATETABLET, EXTENDED RELEASE;ORAL500MG; EQ 50MG BASENoNo
002METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATETABLET, EXTENDED RELEASE;ORAL1GM; EQ 50MG BASENoNo
003METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATETABLET, EXTENDED RELEASE;ORAL1GM; EQ 100MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04
A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04
A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A204144-001AB
A204144-002AB
A204144-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04c2088c7a36db…
2026-10-15 13:18:302026-09A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04c2088c7a36db…
2026-10-15 13:18:302026-09A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04c2088c7a36db…
2026-09-14 22:38:342026-08A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-0484e616aacf4f…
2026-09-14 22:38:342026-08A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-0484e616aacf4f…
2026-09-14 22:38:342026-08A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-0484e616aacf4f…
2026-08-18 06:07:402026-07A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04caaa826d4ba7…
2026-08-18 06:07:402026-07A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORAL2025-06-046a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204144-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204144-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204144-003SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 100MG BASETABLET, EXTENDED RELEASE / ORALAB2025-06-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A204144-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A204144-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A204144-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A204144-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A204144-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A204144-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A204144-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204144-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A204144-003AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204144-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204144-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204144-003AB1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sitagliptin and Metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEPar Health USA, LLC43e3b1c9-3cbd-8dc3-e063-6394a90a10a22025-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204144
application number: ANDA204144

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.