Application 204720

Type
ANDA
Sponsor
UNIQUE PHARM LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIPIZIDEGLIPIZIDETABLET, EXTENDED RELEASE;ORAL2.5MGNoNo
002GLIPIZIDEGLIPIZIDETABLET, EXTENDED RELEASE;ORAL5MGNoNo
003GLIPIZIDEGLIPIZIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo

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
A204720-001GLIPIZIDEGLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29
A204720-002GLIPIZIDEGLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29
A204720-003GLIPIZIDEGLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204720-001AB
A204720-002AB
A204720-003AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALABRS2016-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-002GLIPIZIDE5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-003GLIPIZIDE10MGTABLET, EXTENDED RELEASE / ORALAB2016-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204720-001GLIPIZIDE2.5MGTABLET, EXTENDED RELEASE / ORALAB2016-12-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204720-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204720-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204720-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204720-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204720-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204720-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204720-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204720-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204720-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204720-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204720-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204720-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204720-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204720-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204720-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204720-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204720-001AB18072bd15b7f6…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEREMEDYREPACK INC.03151cb5-d32b-4484-8f2a-8c5d24c7f6f12026-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
ndc (product): 70518-1848
GlipizideGLIPIZIDEREMEDYREPACK INC.c2aadc88-22d2-467c-b2cb-03efb5a1f1c12026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
ndc (product): 70518-1063
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc.548c1f50-dbf0-49cc-b58b-fcc5937affa82026-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
ndc (product): 68788-7856
GlipizideGLIPIZIDEPreferred Pharmaceuticals Inc.4632b4ec-d2f1-40cc-8ef4-256413d8dbec2026-05-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEA-S Medication Solutionsa34b58ac-42b2-4a19-a28b-cb3144ea55cd2026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
ndc (product): 50090-5040
GlipizideGLIPIZIDEREMEDYREPACK INC.bde478e6-e290-47e0-9241-ce88d927633e2026-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
ndc (product): 70518-2308
GlipizideGLIPIZIDERising Pharma Holdings, Inc.0ffe361a-c99b-4f68-a7e2-a67a71c0c4962026-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
ndc (product): 64980-279
ndc (product): 64980-281
ndc (product): 64980-280
GlipizideGLIPIZIDENorthwind Health Company, LLCab2f4ea6-46e8-268a-e053-2995a90a39772026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
ndc (product): 51655-337
GlipizideGLIPIZIDENorthwind Health Company, LLCff9b3b7a-5ab1-45ec-e053-6294a90af4262026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
GlipizideGLIPIZIDEBryant Ranch Prepack0338aff9-29f9-405e-b516-06ef4b8638632024-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
ndc (product): 71335-1130
ndc (product): 71335-1031
ndc (product): 71335-1042
GlipizideGLIPIZIDEA-S Medication Solutions4982f018-c53c-48ec-a4e8-4834228bcf2c2023-11-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204720
application number: ANDA204720
ndc (product): 50090-5806

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 47 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5040GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-5040GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-5806GlipizideGlipizideA-S Medication SolutionsANDACurrent
51655-337GlipizideGlipizideNorthwind PharmaceuticalsANDACurrent
51655-337GlipizideGlipizideNorthwind PharmaceuticalsANDACurrent
60760-165GlipizideGlipizideSt. Mary's Medical Park PharmacyANDACurrent
60760-568GlipizideGlipizideSt. Mary's Medical Park PharmacyANDACurrent
61919-713GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
61919-713GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
61919-713GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
61919-715GlipizideGlipizideDirect_RxANDACurrent
61919-715GlipizideGlipizideDirect_RxANDACurrent
61919-715GlipizideGlipizideDirect_RxANDACurrent
63629-8181GlipizideGlipizideBryant Ranch PrepackANDACurrent
64980-279GlipizideGlipizideRising Pharmaceuticals, Inc.ANDACurrent
64980-280GlipizideGlipizideRising Pharmaceuticals, Inc.ANDACurrent
64980-281GlipizideGlipizideRising Pharmaceuticals, Inc.ANDACurrent
68071-4378GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4378GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4498GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4498GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4498GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7856GlipizideGlipizidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7856GlipizideGlipizidePreferred Pharmaceuticals Inc.ANDACurrent
70518-1063GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1063GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1063GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1063GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1063GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1848GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1848GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1848GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1848GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1848GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-2308GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-2308GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70934-272GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-272GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-1031GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1031GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1031GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1042GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1042GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1042GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1130GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1130GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1130GlipizideGlipizideBryant Ranch PrepackANDACurrent