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 43.

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	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 1 of 6 · 215 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`03ed91905a0d…`

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