Application 075795

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIPIZIDEGLIPIZIDETABLET;ORAL5MGNoNo
002GLIPIZIDEGLIPIZIDETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075795-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORALAB2001-06-13
A075795-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORALABRS2001-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075795-001AB
A075795-002AB

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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075795-002GLIPIZIDE10MGTABLET / ORALABRS2001-06-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075795-002GLIPIZIDE10MGTABLET / ORALAB2001-06-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075795-002GLIPIZIDE10MGTABLET / ORALAB2001-06-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075795-002GLIPIZIDE10MGTABLET / ORALAB2001-06-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075795-002GLIPIZIDE10MGTABLET / ORALAB2001-06-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075795-001GLIPIZIDE5MGTABLET / ORALAB2001-06-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A075795-002GLIPIZIDE10MGTABLET / ORALAB2001-06-13782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075795-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075795-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075795-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075795-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075795-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075795-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075795-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075795-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075795-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075795-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075795-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075795-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075795-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075795-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075795-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075795-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075795-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075795-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075795-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075795-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075795-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075795-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075795-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075795-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075795-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075795-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075795-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075795-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075795-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075795-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075795-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075795-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075795-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075795-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075795-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075795-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075795-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075795-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075795-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075795-002AB1782e0a99824c…

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEREMEDYREPACK INC.376ce3cf-4e1b-4b5f-b3e7-cc9fc4a5aeb42026-06-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
ndc (product): 70518-0579
GlipizideGLIPIZIDEREMEDYREPACK INC.212897cb-7de7-4711-aaf4-44234f950e9f2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
ndc (product): 70518-0552
GlipizideGLIPIZIDEAmerican Health Packagingff6805bb-b5f0-46d3-bf1d-3333b63ff1ae2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDECoupler LLC53e650f1-f755-e3ad-e063-6294a90ae3092026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDECoupler LLC51b35391-7672-c02f-e063-6294a90af54e2026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDECardinal Health 107, LLCbf1f5a5d-79b0-4fc5-96f2-bd5119b56e2a2026-05-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEPreferred Pharmaceuticals, Inc.097424ef-612f-4bc2-809a-e5bb8eeae2442026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
ndc (product): 68788-0142
ndc (product): 68788-0141
GlipizideGLIPIZIDEMajor Pharmaceuticalsd3b5677c-2265-47c8-beeb-bf12106056ba2026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDELegacy Pharmaceutical Packaging, LLC116ffc6a-735c-49e0-a9d5-69b6bc3e37062026-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
ndc (product): 68645-575
ndc (product): 68645-574
GlipizideGLIPIZIDEA-S Medication Solutions9c9a3688-6de9-41db-af82-c4aa9b5b3f922026-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEPD-Rx Pharmaceuticals, Inc.f60b0690-aca9-40ec-956e-bd2ecc35ec542026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
ndc (product): 72789-130
GlipizideGLIPIZIDEA-S Medication Solutions383540fd-2931-49bf-8009-25e8f7fc9bda2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEA-S Medication Solutionsa38cfe61-4aa5-498c-bca5-03a8213303bb2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDENorthwind Health Company, LLC0ed5ed22-dd53-495d-bc10-0bede4d879262026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.6282c653-9e9c-6810-e053-2991aa0a4a8e2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEAvPAKaa1b16bf-e01c-d539-e053-2995a90a27352026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDENorthwind Health Company, LLCc16edad6-4271-6ff0-e053-2a95a90a02402026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEA-S Medication Solutions16fb8bc7-1db1-477e-a201-b3b678b8a84c2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEPD-Rx Pharmaceuticals, Inc.1b2e5656-9da9-4fab-bf01-ed75896b836a2025-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795
GlipizideGLIPIZIDEApotex Corp.dcf426b8-bcdc-8214-a1b6-6388bd3399a02025-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075795
application number: ANDA075795

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 145 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-4232GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4857GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4857GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4857GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68645-574GlipizideGlipizideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-574GlipizideGlipizideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-574GlipizideGlipizideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-575GlipizideGlipizideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-575GlipizideGlipizideLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-575GlipizideGlipizideLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-0141GlipizideGlipizidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0141GlipizideGlipizidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0141GlipizideGlipizidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0141GlipizideGlipizidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0141GlipizideGlipizidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0142GlipizideGlipizidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0142GlipizideGlipizidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0142GlipizideGlipizidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0142GlipizideGlipizidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0142GlipizideGlipizidePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0104GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0552GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0552GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0552GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0552GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0552GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0579GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0579GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0579GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0579GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0579GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0579GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-0579GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70934-098GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-098GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-098GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-300GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-300GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-300GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-666GlipizideGlipizideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-862GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-041GlipizideGlipizideProficient Rx LPANDACurrent
71205-041GlipizideGlipizideProficient Rx LPANDACurrent
71205-041GlipizideGlipizideProficient Rx LPANDACurrent
71205-041GlipizideGlipizideProficient Rx LPANDACurrent
71205-041GlipizideGlipizideProficient Rx LPANDACurrent
71335-0590GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-0590GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-0618GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-0618GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-0930GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-0930GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-0930GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-2050GlipizideGlipizideBryant Ranch PrepackANDACurrent
71610-105GlipizideGlipizideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-175GlipizideGlipizideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-388GlipizideGlipizideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-388GlipizideGlipizideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-393GlipizideGlipizideAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-393GlipizideGlipizideAphena Pharma Solutions - Tennessee, LLCANDACurrent
72789-130GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-130GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-130GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-130GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-130GlipizideGlipizidePD-Rx Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31020ORIG2001-06-13