FDA.reportPublic FDA data

Application 077624

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL1MGNoNo
002GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL2MGNoNo
003GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL4MGNoNo

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
A077624-001GLIMEPIRIDEGLIMEPIRIDE1MGTABLET / ORAL2005-11-28
A077624-002GLIMEPIRIDEGLIMEPIRIDE2MGTABLET / ORAL2005-11-28
A077624-003GLIMEPIRIDEGLIMEPIRIDE4MGTABLET / ORAL2005-11-28

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 22:54:322026-06A077624-001GLIMEPIRIDE1MGTABLET / ORAL2005-11-28a50c72e98297…
2026-08-01 22:54:322026-06A077624-002GLIMEPIRIDE2MGTABLET / ORAL2005-11-28a50c72e98297…
2026-08-01 22:54:322026-06A077624-003GLIMEPIRIDE4MGTABLET / ORAL2005-11-28a50c72e98297…

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 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlimepirideGLIMEPIRIDESt. Mary's Medical Park Pharmacyfc9d8495-184c-3af1-e053-6394a90a5e292026-06-22Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEBryant Ranch Prepack9e863f84-d6f2-4d61-8250-774569e843532026-05-19Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDECardinal Health 107, LLCcc2bc07f-3fab-4df1-85cc-dc0c8e60b4fa2026-05-08Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEPreferred Pharmaceuticals Inc.f69e36b9-4940-4f01-b5ea-59dc66dc1e872026-05-06Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEPreferred Pharmaceuticals Inc.744a5cca-7863-491a-b43a-1b649791702c2026-05-06Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEBryant Ranch Prepack248c3cb3-4501-4b85-bd1d-0624b6afda2c2026-04-13Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEBryant Ranch Prepack90d675cb-6def-49a3-b8b4-229f19d6b6172026-04-13Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.647a146c-c752-4589-8619-aed5c720ca542026-03-19Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.ed7a3a8e-97dd-4a5a-9497-001acfd2f1f02026-03-19Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEAurobindo Pharma Limited28eefc95-d92e-4555-b6c5-2933860b06102026-03-18Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEBryant Ranch Prepack62780d2e-083d-4bcb-99ff-1b1b4ade60d92026-03-09Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.1450f455-a14a-4f9b-b3aa-dae49ea0c1862026-02-26Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDENuCare Pharmaceuticals,Inc.bf8e5993-5ee7-d26d-e053-2a95a90ae5df2026-02-19Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEProficient Rx LPdbed06f9-7758-4c96-9af0-1ed6103db7df2026-02-01Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEProficient Rx LPe12ab052-e3d6-4246-b727-f1e3f9057f092026-02-01Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDECoupler LLC41bf4a72-9288-50a1-e063-6394a90a5e7c2026-01-19Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDERising Pharma Holdings, Inc.48ada723-8144-497d-afd6-a8c52a1dd3ff2026-01-19Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEAvPAK93f1e064-fcbd-e8fd-e053-2995a90a5dbb2026-01-14Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.58c4261e-e98f-4280-9562-2800956dff142026-01-07Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE
GlimepirideGLIMEPIRIDEPD-Rx Pharmaceuticals, Inc.1b3c7d74-f80b-4fb1-8dca-66880af5d3fc2026-01-07Warnings, Adverse reactionsName fallback
brand name: Glimepiride
generic name: GLIMEPIRIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-4011GlimepirideglimepirideMylan Pharmaceuticals IncANDACurrent
0378-4011GlimepirideglimepirideMylan Pharmaceuticals Inc.ANDACurrent
0378-4012GlimepirideglimepirideMylan Pharmaceuticals IncANDACurrent
0378-4012GlimepirideglimepirideMylan Pharmaceuticals Inc.ANDACurrent
0378-4013GlimepirideglimepirideMylan Pharmaceuticals IncANDACurrent
0378-4013GlimepirideglimepirideMylan Pharmaceuticals Inc.ANDACurrent
51079-425GlimepirideglimepirideMylan Institutional Inc.ANDACurrent
51079-425GlimepirideglimepirideMylan Institutional Inc.ANDACurrent
51079-426GlimepirideglimepirideMylan Institutional Inc.ANDACurrent
51079-426GlimepirideglimepirideMylan Institutional Inc.ANDACurrent
55154-5070GlimepirideglimepirideCardinal HealthANDACurrent