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 1 .
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.
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 2026-08-01 22:54:32 2026-06 A200082-001 EZETIMIBE AND SIMVASTATIN 10MG;10MG TABLET / ORAL AB 2020-12-17 a50c72e98297…2026-08-01 22:54:32 2026-06 A200082-002 EZETIMIBE AND SIMVASTATIN 10MG;20MG TABLET / ORAL AB 2020-12-17 a50c72e98297…2026-08-01 22:54:32 2026-06 A200082-003 EZETIMIBE AND SIMVASTATIN 10MG;40MG TABLET / ORAL AB 2020-12-17 a50c72e98297…2026-08-01 22:54:32 2026-06 A200082-004 EZETIMIBE AND SIMVASTATIN 10MG;80MG TABLET / ORAL AB 2020-12-17 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.