FDA.reportPublic FDA data

Application 202388

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SITAGLIPTIN; METFORMIN HYDROCHLORIDESITAGLIPTIN; METFORMIN HYDROCHLORIDETABLET; ORAL50MG; 500MGNoNo
002SITAGLIPTIN; METFORMIN HYDROCHLORIDESITAGLIPTIN; METFORMIN HYDROCHLORIDETABLET; ORAL50MG; 1000MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202388-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE500MG;EQ 50MG BASETABLET / ORALAB2025-12-02
A202388-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE1GM;EQ 50MG BASETABLET / ORALAB2025-12-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202388-001AB
A202388-002AB

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A202388-001PC2026-11-24
A202388-002PC2026-11-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202388-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET / ORALAB2025-12-0284e616aacf4f…
2026-09-14 22:38:342026-08A202388-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET / ORALAB2025-12-0284e616aacf4f…
2026-08-18 06:07:402026-07A202388-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET / ORALAB2025-12-02caaa826d4ba7…
2026-08-18 06:07:402026-07A202388-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET / ORALAB2025-12-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202388-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET / ORALAB2025-12-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202388-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET / ORALAB2025-12-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202388-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET / ORALAB2025-12-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202388-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET / ORALAB2025-12-0231067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202388-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET / ORALAB2025-12-02a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202388-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET / ORALAB2025-12-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202388-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202388-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A202388-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202388-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202388-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202388-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202388-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202388-002AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202388-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202388-002AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08A202388-001PC2026-11-2484e616aacf4f…
2026-09-14 22:38:342026-08A202388-002PC2026-11-2484e616aacf4f…
2026-08-18 06:07:402026-07A202388-001PC2026-11-24caaa826d4ba7…
2026-08-18 06:07:402026-07A202388-002PC2026-11-24caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202388-001PC2026-11-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A202388-002PC2026-11-24a50c72e98297…

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 HYDROCHLORIDESandoz Inca0fcdc08-0afc-4912-a126-3efea6bc8c612025-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202388
application number: ANDA202388

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84745ORIG 2026-01-13