FDA.reportPublic FDA data

Application 020496

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMARYLGLIMEPIRIDETABLET;ORAL1MGYesYes
002AMARYLGLIMEPIRIDETABLET;ORAL2MGYesNo
003AMARYLGLIMEPIRIDETABLET;ORAL4MGYesNo

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
N020496-001AMARYLGLIMEPIRIDE1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-11-30
N020496-002AMARYLGLIMEPIRIDE2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-11-30
N020496-003AMARYLGLIMEPIRIDE4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-11-30

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2026-08-01 22:54:322026-06N020496-001AMARYL1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-11-30a50c72e98297…
2026-08-01 22:54:322026-06N020496-002AMARYL2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-11-30a50c72e98297…
2026-08-01 22:54:322026-06N020496-003AMARYL4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1995-11-30a50c72e98297…

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

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
0039-0221AMARYLglimepirideSanofi-Aventis U.S. LLCNDACurrent
0039-0221AMARYLglimepirideSanofi-Aventis U.S. LLCNDACurrent
0039-0222AMARYLglimepirideSanofi-Aventis U.S. LLCNDACurrent
0039-0222AMARYLglimepirideSanofi-Aventis U.S. LLCNDACurrent
0039-0223AMARYLglimepirideSanofi-Aventis U.S. LLCNDACurrent
0039-0223AMARYLglimepirideSanofi-Aventis U.S. LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57651ORIG2019-02-15
57073SUPPL2018-12-31
57013SUPPL2018-12-26
46490SUPPL2016-12-22
46494SUPPL2016-12-21
12637SUPPL2013-10-22
25049SUPPL2013-10-18
12636SUPPL2013-08-09
25048SUPPL2013-08-05
25047SUPPL2012-02-08
34713SUPPL2012-02-06
25046SUPPL2009-06-16
34712SUPPL2009-06-04
25045SUPPL2009-02-13
2603SUPPL2009-02-13
34711SUPPL2009-02-04
12635SUPPL2009-02-04
25044SUPPL2005-12-06
34709SUPPL2005-12-05
34710SUPPL2005-09-22
2602SUPPL2005-09-22
25043SUPPL2004-08-25
20684SUPPL2004-05-27
2601SUPPL2002-04-15
20683SUPPL1999-02-24
2600SUPPL1999-02-24
51967SUPPL1900-01-01
51966SUPPL1900-01-01
51965SUPPL1900-01-01