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 45.

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
2026-11-14 07:37:172026-10A202388-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET / ORALAB2025-12-02d4dbc9d85df4…
2026-11-14 07:37:172026-10A202388-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET / ORALAB2025-12-02d4dbc9d85df4…
2026-10-15 13:18:302026-09A202388-001SITAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 50MG BASETABLET / ORALAB2025-12-02c2088c7a36db…
2026-10-15 13:18:302026-09A202388-002SITAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 50MG BASETABLET / ORALAB2025-12-02c2088c7a36db…
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
2026-11-14 07:37:172026-10A202388-001AB1d4dbc9d85df4…
2026-11-14 07:37:172026-10A202388-002AB1d4dbc9d85df4…
2026-10-15 13:18:302026-09A202388-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A202388-002AB1c2088c7a36db…
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
2026-11-14 07:37:172026-10A202388-001PC2026-11-24d4dbc9d85df4…
2026-11-14 07:37:172026-10A202388-002PC2026-11-24d4dbc9d85df4…
2026-10-15 13:18:302026-09A202388-001PC2026-11-24c2088c7a36db…
2026-10-15 13:18:302026-09A202388-002PC2026-11-24c2088c7a36db…
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…

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