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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PioglitazonePIOGLITAZONERising Pharma Holdings, Inc.4483b1c6-7095-4a63-8128-ac2d91e110402025-05-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PIOGLITAZONE HYDROCHLORIDEPIOGLITAZONE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.31619517-a590-408a-ae9e-76c99f0a0a1d2025-03-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONEPIOGLITAZONEDIRECT RXa7e8d5a3-b0da-1d70-e053-2a95a90aa4352025-01-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PIOGLITAZONE
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.bde7fa79-aafc-3ba0-e053-2a95a90aa4d22025-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONEBryant Ranch Prepackf6cad01e-cd65-4c8d-9e49-399404f220052024-12-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.af863b9e-9646-3b1e-e053-2995a90ab93a2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.a4751cb4-0700-dd22-e053-2995a90adfdb2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.a1112e4b-e9d5-13c3-e053-2995a90a6d0a2024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.a0846e3e-68b2-fd55-e053-2995a90a673e2024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONENuCare Pharmaceuticals,Inc.8d5ac747-991f-30e4-e053-2a95a90a47802024-06-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONEProficient Rx LPf725cdaf-fc7a-40d6-ba64-1dccd1b25d7a2024-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONEA-S Medication Solutions9fe57786-5c7d-4b11-8fb4-de341e2e51282023-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONEA-S Medication Solutions4b5506c4-8cc2-44fb-ba2b-0e29fb73943d2023-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONEA-S Medication Solutions475c4f39-dd2a-48f9-a07c-9344bbda58a92023-04-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONEA-S Medication Solutions5f844e44-0f0d-4b28-9d34-b97780e1c6ec2023-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONEMacleods Pharmaceuticals Limited482cef76-0623-4b4f-a0ea-f008c97b22812022-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONENorthStar RxLLC692e662a-3b31-42c3-a075-42abe44c74db2022-09-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONETeva Pharmaceuticals USA, Inc.c5c81c67-90cf-4e64-acb5-58b0358fa7422021-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PioglitazonePIOGLITAZONEAphena Pharma Solutions - Tennessee, LLCf434ba0d-13f3-42ae-a2d5-cddb93fde1e82020-12-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Pioglitazone
PIOGLITAZONEPIOGLITAZONESolco Healthcare LLC1b77dbeb-61d1-4df3-872b-2f4f75a110db2020-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PIOGLITAZONE

Reported adverse events (FAERS/openFDA)#

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

Documents#

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