FDA.reportPublic FDA data

Application 077337

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATETABLET;ORAL500MG;EQ 2MG BASENoNo
002ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATETABLET;ORAL500MG;EQ 4MG BASENoNo
003ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATETABLET;ORAL1GM;EQ 2MG BASENoNo
004ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATETABLET;ORAL1GM;EQ 4MG BASENoNo
005ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATETABLET;ORAL500MG;EQ 1MG BASENoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077337-001ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE500MG;EQ 2MG BASETABLET / ORAL2014-05-07
A077337-002ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE500MG;EQ 4MG BASETABLET / ORAL2014-05-07
A077337-003ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE1GM;EQ 2MG BASETABLET / ORAL2014-05-07
A077337-004ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE1GM;EQ 4MG BASETABLET / ORAL2014-05-07
A077337-005ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE500MG;EQ 1MG BASETABLET / ORAL2017-05-19

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 6 of 6 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A077337-001ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE500MG;EQ 2MG BASETABLET / ORAL2014-05-07f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A077337-002ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE500MG;EQ 4MG BASETABLET / ORAL2014-05-07f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A077337-003ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE1GM;EQ 2MG BASETABLET / ORAL2014-05-07f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A077337-004ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE1GM;EQ 4MG BASETABLET / ORAL2014-05-07f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A077337-005ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE500MG;EQ 1MG BASETABLET / ORAL2017-05-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077337-001ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE500MG;EQ 2MG BASETABLET / ORAL2014-05-07e64feba35796…
2022-09-29 23:25 UTC2022-09A077337-002ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE500MG;EQ 4MG BASETABLET / ORAL2014-05-07e64feba35796…
2022-09-29 23:25 UTC2022-09A077337-003ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE1GM;EQ 2MG BASETABLET / ORAL2014-05-07e64feba35796…
2022-09-29 23:25 UTC2022-09A077337-004ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE1GM;EQ 4MG BASETABLET / ORAL2014-05-07e64feba35796…
2022-09-29 23:25 UTC2022-09A077337-005ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE500MG;EQ 1MG BASETABLET / ORAL2017-05-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077337-001ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE500MG;EQ 2MG BASETABLET / ORAL2014-05-07cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077337-002ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE500MG;EQ 4MG BASETABLET / ORAL2014-05-07cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077337-003ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE1GM;EQ 2MG BASETABLET / ORAL2014-05-07cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077337-004ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE1GM;EQ 4MG BASETABLET / ORAL2014-05-07cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077337-005ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE500MG;EQ 1MG BASETABLET / ORAL2017-05-19cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077337-001ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE500MG;EQ 2MG BASETABLET / ORAL2014-05-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077337-002ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE500MG;EQ 4MG BASETABLET / ORAL2014-05-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077337-003ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE1GM;EQ 2MG BASETABLET / ORAL2014-05-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077337-004ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE1GM;EQ 4MG BASETABLET / ORAL2014-05-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077337-005ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE500MG;EQ 1MG BASETABLET / ORAL2017-05-19a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48644SUPPL2017-06-05
48537ORIG2017-05-25
39527ORIG2014-08-05
9037ORIG2014-05-09