FDA.reportPublic FDA data

Application 208459

Type
ANDA
Sponsor
MSN LABS PVT LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;500MGNoNo
002LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;850MGNoNo
003LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;1GMNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208459-001LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN; METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2025-11-03
A208459-002LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN; METFORMIN HYDROCHLORIDE2.5MG;850MGTABLET / ORALAB2025-11-03
A208459-003LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN; METFORMIN HYDROCHLORIDE2.5MG;1GMTABLET / ORALAB2025-11-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208459-001AB
A208459-002AB
A208459-003AB

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
2026-09-14 22:38:342026-08A208459-001LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2025-11-0384e616aacf4f…
2026-09-14 22:38:342026-08A208459-002LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;850MGTABLET / ORALAB2025-11-0384e616aacf4f…
2026-09-14 22:38:342026-08A208459-003LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;1GMTABLET / ORALAB2025-11-0384e616aacf4f…
2026-08-18 06:07:402026-07A208459-001LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2025-11-03caaa826d4ba7…
2026-08-18 06:07:402026-07A208459-002LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;850MGTABLET / ORALAB2025-11-03caaa826d4ba7…
2026-08-18 06:07:402026-07A208459-003LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;1GMTABLET / ORALAB2025-11-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208459-001LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2025-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208459-002LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;850MGTABLET / ORALAB2025-11-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208459-003LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;1GMTABLET / ORALAB2025-11-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208459-001LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2025-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208459-002LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;850MGTABLET / ORALAB2025-11-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208459-003LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;1GMTABLET / ORALAB2025-11-0331067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208459-001LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2025-11-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208459-002LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;850MGTABLET / ORALAB2025-11-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208459-003LINAGLIPTIN AND METFORMIN HYDROCHLORIDE2.5MG;1GMTABLET / ORALAB2025-11-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208459-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208459-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A208459-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A208459-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208459-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208459-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208459-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208459-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208459-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208459-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208459-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208459-003AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208459-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208459-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A208459-003AB1a50c72e98297…

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
Linagliptin and metformin hydrochlorideLINAGLIPTIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLC5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb2025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208459
application number: ANDA208459

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55949ORIG2018-10-15