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	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 3 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077337-001	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077337-002	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077337-003	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 2MG BASE	TABLET / ORAL	2014-05-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077337-004	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	1GM;EQ 4MG BASE	TABLET / ORAL	2014-05-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077337-005	ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE	500MG;EQ 1MG BASE	TABLET / ORAL	2017-05-19	`87673890dc5c…`

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