FDA.reportPublic FDA data

Application 206081

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL500MG;EQ 5MG BASENoNo
002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1GM;EQ 2.5MG BASENoNo
003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL1GM;EQ 5MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORAL2023-07-31
A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORAL2023-07-31
A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORAL2023-07-31

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.

Product history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORAL2023-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORAL2023-07-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORAL2023-07-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORAL2023-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORAL2023-07-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORAL2023-07-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORAL2023-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORAL2023-07-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORAL2023-07-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206081-002SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 2.5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206081-003SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE1GM;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206081-001SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE500MG;EQ 5MG BASETABLET, EXTENDED RELEASE / ORALAB2023-07-318072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206081-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206081-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206081-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206081-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206081-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206081-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206081-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206081-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206081-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206081-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206081-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206081-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206081-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206081-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206081-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206081-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206081-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206081-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206081-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206081-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206081-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206081-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206081-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206081-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206081-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206081-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206081-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206081-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206081-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206081-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206081-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206081-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206081-003AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206081-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206081-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206081-003AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206081-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A206081-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A206081-003AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206081-001AB1ea1830bbd6c7…

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
Saxagliptin and Metformin HydrochlorideSAXAGLIPTIN AND METFORMIN HYDROCHLORIDEDr.Reddys Laboratories Inc65884427-4dde-63bb-a23f-36a7779c0a6b2026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Saxagliptin and Metformin Hydrochloride

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62985ORIG2020-05-14