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 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
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
2026-07-26 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
2026-07-26 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 1 of 6 · 106 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Glucotrol XLGLIPIZIDERoerigeed99b60-d043-4249-9b2a-f05e46fb588d2026-07-21Warnings, Adverse reactionsName fallback
generic name: GLIPIZIDE
GlipizideGLIPIZIDEREMEDYREPACK INC.03151cb5-d32b-4484-8f2a-8c5d24c7f6f12026-07-14Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEANI Pharmaceuticals, Inc.252ba4e0-8dc3-43e3-be00-32570dc095bd2026-07-13Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEREMEDYREPACK INC.c2aadc88-22d2-467c-b2cb-03efb5a1f1c12026-07-02Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEREMEDYREPACK INC.376ce3cf-4e1b-4b5f-b3e7-cc9fc4a5aeb42026-06-29Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEREMEDYREPACK INC.212897cb-7de7-4711-aaf4-44234f950e9f2026-06-26Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEAmerican Health Packagingff6805bb-b5f0-46d3-bf1d-3333b63ff1ae2026-06-24Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDESt. Mary's Medical Park Pharmacy1b2ef6e2-5e7c-761e-e063-6294a90addd02026-06-22Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDENuCare Pharmaceuticals, Inc.4c4dfe64-d1c5-65ec-e063-6394a90aead52026-06-19Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEBryant Ranch Prepack06fb6c56-5609-41d9-8389-eba81432218d2026-06-11Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEBryant Ranch Prepack5ca7e38b-84cb-4043-b97e-e2f5cd82b4422026-06-11Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDECoupler LLC53e650f1-f755-e3ad-e063-6294a90ae3092026-06-10Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEREMEDYREPACK INC.0df8f606-97b3-463c-a132-338cf4630a712026-06-10Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEPD-Rx Pharmaceuticals, Inc.c8cfd137-7b41-460f-a463-141c9d1985ff2026-06-04Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDESt. Mary's Medical Park Pharmacy0ccc17ca-fff8-0449-e063-6294a90af36d2026-06-03Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEBryant Ranch Prepack9b405ff3-6ce5-460a-9406-db92e0e6ab1b2026-05-21Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutions69a21bd3-3364-4035-b098-3808cc8cf8b22026-05-17Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEA-S Medication Solutionsc582d7d0-4db0-4296-8131-baefd1a671b22026-05-17Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDECoupler LLC51b35391-7672-c02f-e063-6294a90af54e2026-05-13Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE
GlipizideGLIPIZIDEBryant Ranch Prepack2aa01a7e-a703-426f-9cd3-70b88d0a8e7f2026-05-13Warnings, Adverse reactionsName fallback
brand name: Glipizide
generic name: GLIPIZIDE