FDA.reportPublic FDA data

Application 077507

Type
ANDA
Sponsor
EPIC PHARMA LLC

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 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
A077507-001GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2005-10-27
A077507-002GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-10-27
A077507-003GLIPIZIDE AND METFORMIN HYDROCHLORIDEGLIPIZIDE; METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077507-001AB
A077507-002AB
A077507-003AB

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
2026-08-01 22:54:322026-06A077507-001GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;250MGTABLET / ORALAB2005-10-27a50c72e98297…
2026-08-01 22:54:322026-06A077507-002GLIPIZIDE AND METFORMIN HYDROCHLORIDE2.5MG;500MGTABLET / ORALAB2005-10-27a50c72e98297…
2026-08-01 22:54:322026-06A077507-003GLIPIZIDE AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET / ORALAB2005-10-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077507-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077507-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077507-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 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 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 HYDROCHLORIDEREMEDYREPACK INC.3f2599c6-9e33-487e-9379-6477bb1214612026-01-09Boxed 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
Glipizide and Metformin HydrochlorideGLIPIZIDE AND METFORMIN HYDROCHLORIDETeva Pharmaceuticals USA, Inc.03d9ce02-0559-494c-a53d-de9b9a64b6062020-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Glipizide and Metformin Hydrochloride

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9055ORIG2005-11-01