Home Applications 076798 Application 076798
Type ANDA
Sponsor CELLTRION Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 15MG BASE No No 002 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 30MG BASE No No 003 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE TABLET;ORAL EQ 45MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076798-001 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 A076798-002 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 A076798-003 PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A076798-003 PIOGLITAZONE HYDROCHLORIDE EQ 45MG BASE TABLET / ORAL AB 2012-10-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076798-001 PIOGLITAZONE HYDROCHLORIDE EQ 15MG BASE TABLET / ORAL AB 2012-10-26 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A076798-002 PIOGLITAZONE HYDROCHLORIDE EQ 30MG BASE TABLET / ORAL AB 2012-10-26 c0c555d07b60…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-2639 Pioglitazone Hydrochloride Pioglitazone Hydrochloride A-S Medication Solutions ANDA Current 50090-5582 Pioglitazone Hydrochloride Pioglitazone Hydrochloride A-S Medication Solutions ANDA Current 50090-5582 Pioglitazone Hydrochloride Pioglitazone Hydrochloride A-S Medication Solutions ANDA Current 68788-6420 Pioglitazone Hydrochloride Pioglitazone Hydrochloride Preferred Pharmaceuticals Inc. ANDA Current 71335-2027 Pioglitazone Hydrochloride Pioglitazone Hydrochloride Bryant Ranch Prepack ANDA Current 71335-2082 Pioglitazone Hydrochloride Pioglitazone Hydrochloride Bryant Ranch Prepack ANDA Current 72606-501 Pioglitazone Hydrochloride Pioglitazone Hydrochloride CELLTRION USA, INC. ANDA Current 72606-502 Pioglitazone Hydrochloride Pioglitazone Hydrochloride CELLTRION USA, INC. ANDA Current 72606-503 Pioglitazone Hydrochloride Pioglitazone Hydrochloride CELLTRION USA, INC. ANDA Current 72606-570 Pioglitazone Hydrochloride Pioglitazone Hydrochloride CELLTRION USA, INC. ANDA Current 72606-571 Pioglitazone Hydrochloride Pioglitazone Hydrochloride CELLTRION USA, INC. ANDA Current 72606-572 Pioglitazone Hydrochloride Pioglitazone Hydrochloride CELLTRION USA, INC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8965 ORIG 2012-08-23 44321 ORIG 2009-11-12