Home Applications 077337 Application 077337
Type ANDA
Sponsor TEVA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE TABLET;ORAL 500MG;EQ 2MG BASE No No 002 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE TABLET;ORAL 500MG;EQ 4MG BASE No No 003 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE TABLET;ORAL 1GM;EQ 2MG BASE No No 004 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE TABLET;ORAL 1GM;EQ 4MG BASE No No 005 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE TABLET;ORAL 500MG;EQ 1MG 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077337-001 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500MG;EQ 2MG BASE TABLET / ORAL 2014-05-07 A077337-002 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500MG;EQ 4MG BASE TABLET / ORAL 2014-05-07 A077337-003 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 1GM;EQ 2MG BASE TABLET / ORAL 2014-05-07 A077337-004 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 1GM;EQ 4MG BASE TABLET / ORAL 2014-05-07 A077337-005 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE 500MG;EQ 1MG BASE TABLET / ORAL 2017-05-19
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 4 of 6 · 220 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 2021-03-12 10:30 UTC 2021-03 A077337-001 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 2MG BASE TABLET / ORAL 2014-05-07 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A077337-002 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 4MG BASE TABLET / ORAL 2014-05-07 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A077337-003 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 2MG BASE TABLET / ORAL 2014-05-07 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A077337-004 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 4MG BASE TABLET / ORAL 2014-05-07 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A077337-005 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 1MG BASE TABLET / ORAL 2017-05-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077337-001 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 2MG BASE TABLET / ORAL 2014-05-07 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A077337-002 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 4MG BASE TABLET / ORAL 2014-05-07 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A077337-003 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 2MG BASE TABLET / ORAL 2014-05-07 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A077337-004 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 4MG BASE TABLET / ORAL 2014-05-07 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A077337-005 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 1MG BASE TABLET / ORAL 2017-05-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077337-001 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 2MG BASE TABLET / ORAL 2014-05-07 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A077337-002 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 4MG BASE TABLET / ORAL 2014-05-07 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A077337-003 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 2MG BASE TABLET / ORAL 2014-05-07 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A077337-004 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 4MG BASE TABLET / ORAL 2014-05-07 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A077337-005 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 1MG BASE TABLET / ORAL 2017-05-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077337-001 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 2MG BASE TABLET / ORAL 2014-05-07 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A077337-002 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 4MG BASE TABLET / ORAL 2014-05-07 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A077337-003 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 2MG BASE TABLET / ORAL 2014-05-07 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A077337-004 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 4MG BASE TABLET / ORAL 2014-05-07 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A077337-005 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 1MG BASE TABLET / ORAL 2017-05-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077337-001 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 2MG BASE TABLET / ORAL 2014-05-07 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A077337-002 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 4MG BASE TABLET / ORAL 2014-05-07 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A077337-003 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 2MG BASE TABLET / ORAL 2014-05-07 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A077337-004 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 4MG BASE TABLET / ORAL 2014-05-07 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A077337-005 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 1MG BASE TABLET / ORAL 2017-05-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077337-001 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 2MG BASE TABLET / ORAL 2014-05-07 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A077337-002 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 4MG BASE TABLET / ORAL 2014-05-07 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A077337-003 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 2MG BASE TABLET / ORAL 2014-05-07 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A077337-004 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 4MG BASE TABLET / ORAL 2014-05-07 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A077337-005 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 1MG BASE TABLET / ORAL 2017-05-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077337-001 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 2MG BASE TABLET / ORAL 2014-05-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077337-002 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 4MG BASE TABLET / ORAL 2014-05-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077337-003 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 2MG BASE TABLET / ORAL 2014-05-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077337-004 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 4MG BASE TABLET / ORAL 2014-05-07 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077337-005 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 1MG BASE TABLET / ORAL 2017-05-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077337-001 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 2MG BASE TABLET / ORAL 2014-05-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A077337-002 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 4MG BASE TABLET / ORAL 2014-05-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A077337-003 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 2MG BASE TABLET / ORAL 2014-05-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A077337-004 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 1GM;EQ 4MG BASE TABLET / ORAL 2014-05-07 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A077337-005 ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 500MG;EQ 1MG BASE TABLET / ORAL 2017-05-19 1c564ffb4f44…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 48644 SUPPL 2017-06-05 48537 ORIG 2017-05-25 39527 ORIG 2014-08-05 9037 ORIG 2014-05-09