FDA.reportPublic FDA data

Application 219159

Type
ANDA
Sponsor
GRAVITI PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A219159-001GLIPIZIDEGLIPIZIDE5MGTABLET / ORALAB2026-03-04
A219159-002GLIPIZIDEGLIPIZIDE10MGTABLET / ORALAB2026-03-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219159-001AB
A219159-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A219159-001GLIPIZIDE5MGTABLET / ORALAB2026-03-0484e616aacf4f…
2026-09-14 22:38:342026-08A219159-002GLIPIZIDE10MGTABLET / ORALAB2026-03-0484e616aacf4f…
2026-08-18 06:07:402026-07A219159-001GLIPIZIDE5MGTABLET / ORALAB2026-03-04caaa826d4ba7…
2026-08-18 06:07:402026-07A219159-002GLIPIZIDE10MGTABLET / ORALAB2026-03-04caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219159-001GLIPIZIDE5MGTABLET / ORALAB2026-03-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219159-002GLIPIZIDE10MGTABLET / ORALAB2026-03-04a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219159-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A219159-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A219159-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A219159-002AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219159-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219159-002AB1a50c72e98297…

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 5 of 6 · 102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlipizideGLIPIZIDEAdvanced Rx of Tennessee, LLC213c4e61-9bb7-9d1b-e063-6394a90a73392024-09-03Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEBryant Ranch Prepackafb65cc1-a4fb-4771-b09c-dcf6e8c5786e2024-08-26Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENuCare Pharmaceuticals, Inc.3e295cbc-37c1-4e25-e054-00144ff8d46c2024-08-13Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.589dc76d-c347-0589-e053-2991aa0a25202024-07-18Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.8c27962d-626b-30e6-e053-2a95a90a49c62024-06-18Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.7c21db4d-6b9b-36c3-e053-2991aa0a0fd92024-06-12Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENuCare Pharmaceuticals,Inc.62d569b8-bb34-0e06-e053-2a91aa0a2ae12024-06-06Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEAphena Pharma Solutions - Tennessee, LLCf620559f-985b-421f-98df-bc2ca1cb0ece2024-02-26Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEActavis Pharma, Inc.ad55dfd7-ffb5-478a-aa84-1009fa921e222023-12-31Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions0874340a-75a1-4ac9-b224-80c5c24e1b412023-12-28Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions5014a2d7-e0d3-4e84-9a3e-c90b398b8c6c2023-12-04Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions15308fc4-11e3-4cd5-8f04-ab8e3433cc7d2023-12-04Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions4982f018-c53c-48ec-a4e8-4834228bcf2c2023-11-24Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions08b01608-73c2-45e0-8de4-c6c4012611522023-10-23Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions695c178f-77f0-451e-b718-72b65e495b7e2023-10-18Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDETruPharma LLC95ea4c96-84b9-4515-9494-a93d26820f702023-10-11Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEAphena Pharma Solutions - Tennessee, LLC64c2a82f-014c-47d7-b303-23531e6bb7232023-04-14Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENCS HealthCare of KY, LLC dba Vangard Labsbf5ff427-3ee4-4064-a55e-35daa2f12a062023-02-27Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEProficient Rx LPf280acc1-d912-4f2e-b131-440e708c7b1f2022-07-01Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEProficient Rx LP31618a34-b87b-484c-8b65-1f77d8cd0f282022-04-01Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.