FDA.reportPublic FDA data

Application 078083

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;250MGNoNo
002GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;500MGNoNo
003GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDETABLET;ORAL5MG;500MGNoNo

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
A078083-001GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORAL2007-04-12
A078083-002GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORAL2007-04-12
A078083-003GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORAL2007-04-12

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A078083-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORAL2007-04-12f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078083-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORAL2007-04-12f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A078083-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORAL2007-04-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078083-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORAL2007-04-12e64feba35796…
2022-09-29 23:25 UTC2022-09A078083-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORAL2007-04-12e64feba35796…
2022-09-29 23:25 UTC2022-09A078083-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORAL2007-04-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078083-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORAL2007-04-12cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078083-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORAL2007-04-12cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078083-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORAL2007-04-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078083-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORAL2007-04-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078083-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORAL2007-04-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A078083-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORAL2007-04-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A078083-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078083-003AB174a2ff9319b5…
2019-09-15 20:21 UTC2019-09A078083-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A078083-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078083-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A078083-003AB1ea99ee380514…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.1b18b903-eb52-4d08-b4a5-f984957eb1162026-06-27Warnings, Adverse reactionsName fallback
brand name: Glipizide and Metformin Hydrochloride
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDETeva Pharmaceuticals USA, Inc.03d9ce02-0559-494c-a53d-de9b9a64b6062026-06-11Warnings, Adverse reactionsName fallback
brand name: Glipizide and Metformin Hydrochloride
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEA-S Medication Solutions4a2d814b-93a1-4487-b789-dbafe9f0ffd32026-03-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glipizide and Metformin Hydrochloride
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEAvKARE13be49d2-0ce9-a78a-e557-ded85ddc808f2025-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glipizide and Metformin Hydrochloride
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limitedbd2e1c06-424b-4222-b723-90ffdcc3983c2024-11-30Name fallback
brand name: Glipizide and Metformin Hydrochloride

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-3131Glipizide and Metformin Hydrochlorideglipizide and metformin hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-3132Glipizide and Metformin Hydrochlorideglipizide and metformin hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-3132Glipizide and Metformin Hydrochlorideglipizide and metformin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3133Glipizide and Metformin Hydrochlorideglipizide and metformin hydrochlorideMylan Pharmaceuticals IncANDACurrent
0378-3133Glipizide and Metformin Hydrochlorideglipizide and metformin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
70518-0116Glipizide and Metformin Hydrochlorideglipizide and metformin hydrochlorideREMEDYREPACK INC.ANDACurrent