Home Applications 200082 Application 200082
Type ANDA
Sponsor MYLAN PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EZETIMIBE; SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET; ORAL 10MG; 10MG No No 002 EZETIMIBE; SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET; ORAL 10MG; 20MG No No 003 EZETIMIBE; SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET; ORAL 10MG; 40MG No No 004 EZETIMIBE; SIMVASTATIN EZETIMIBE; SIMVASTATIN TABLET; ORAL 10MG; 80MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A200082-001 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 A200082-002 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 A200082-003 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 A200082-004 EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 4 of 4 · 148 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 2023-05-13 08:27 UTC 2023-05 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL 2020-12-17 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL 2020-12-17 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL 2020-12-17 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL 2020-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL 2020-12-17 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL 2020-12-17 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL 2020-12-17 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL 2020-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL 2020-12-17 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL 2020-12-17 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL 2020-12-17 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL 2020-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL 2020-12-17 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL 2020-12-17 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL 2020-12-17 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL 2020-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL 2020-12-17 e64feba35796…2022-09-29 23:25 UTC 2022-09 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL 2020-12-17 e64feba35796…2022-09-29 23:25 UTC 2022-09 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL 2020-12-17 e64feba35796…2022-09-29 23:25 UTC 2022-09 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL 2020-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL 2020-12-17 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL 2020-12-17 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL 2020-12-17 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL 2020-12-17 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17 a50c72e98297…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 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.