FDA.reportPublic FDA data

Application 076799

Type
ANDA
Sponsor
ALPHAPHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIOGLITAZONEPIOGLITAZONE HYDROCHLORIDETABLET; ORAL15MGNoNo
002PIOGLITAZONEPIOGLITAZONE HYDROCHLORIDETABLET; ORAL30MGNoNo
003PIOGLITAZONEPIOGLITAZONE HYDROCHLORIDETABLET; ORAL45MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEGSMS, Incorporatedd740d2a2-b26d-4b16-aedc-e4b4b1c94daa2026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PIOGLITAZONE HYDROCHLORIDE
PioglitazonePIOGLITAZONEMajor Pharmaceuticals72b46a1e-d9ea-4a47-95ef-5eae96ef1e7f2026-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEA-S Medication Solutions6cd7c8b7-f5d4-423b-ae9f-86541869d8cf2026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PIOGLITAZONE HYDROCHLORIDE
PioglitazonePIOGLITAZONEBryant Ranch Prepack466ef4c8-84d4-4ded-8505-a33f12adf31c2026-03-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEA-S Medication Solutionse64b46e5-3c94-4635-908e-cdc2263bd3d42026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PIOGLITAZONE HYDROCHLORIDE
PioglitazonePIOGLITAZONEBryant Ranch Prepackfbdaaa34-06c4-49af-85b4-91a85922b30b2026-02-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONEREMEDYREPACK INC.3a9f6777-9b4f-482a-aa4e-4900f9d35b8e2026-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONEREMEDYREPACK INC.55f9b2d8-3e78-4e2f-bcf1-d00595078fa12026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEA-S Medication Solutions41a9586c-8768-4fc3-bb78-e6d98b09030b2026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PIOGLITAZONE HYDROCHLORIDE
PioglitazonePIOGLITAZONEAvKARE22569835-bc9f-7787-e063-6394a90a62322026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONEAmerican Health Packagingf3a2222d-5156-4533-bb4b-74652c8eb9c72026-01-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEA-S Medication Solutions29073b0a-1d7e-4354-87c7-e764106978d82026-01-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEREMEDYREPACK INC.04577c39-a9c0-4c66-a775-4c79e2c3dea52025-11-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEChartwell RX, LLC699e865a-952e-459e-a871-9b7cce475b712025-11-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PIOGLITAZONE HYDROCHLORIDE
PioglitazonePIOGLITAZONEPreferred Pharmaceuticals, Inc.164c444c-7c56-4482-9cbd-0e0f0ad30c442025-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONEPreferred Pharmaceuticals, Inc.060e3169-46a7-419d-9acc-05586cb2406b2025-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEBryant Ranch Prepackc9548800-4c44-473d-a89b-c705484548b32025-06-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PIOGLITAZONE HYDROCHLORIDE
PioglitazonePIOGLITAZONEBryant Ranch Prepack6397fb4c-081b-4abd-ab4b-0a3fbf99e6632025-06-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEAurobindo Pharma Limited1f259863-21fd-4d62-b094-4eff845944df2025-05-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEQUALLENT PHARMACEUTICALS HEALTH LLC0331400c-b163-4856-bfb0-965470247cb32025-05-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PIOGLITAZONE HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23837ORIG2009-11-12