Home Applications 211394 Application 211394
Type ANDA
Sponsor YILING Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SIMVASTATIN SIMVASTATIN TABLET;ORAL 10MG No No 002 SIMVASTATIN SIMVASTATIN TABLET;ORAL 20MG No No 003 SIMVASTATIN SIMVASTATIN TABLET;ORAL 40MG No No 004 SIMVASTATIN SIMVASTATIN TABLET;ORAL 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 A211394-001 SIMVASTATIN SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 A211394-002 SIMVASTATIN SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 A211394-003 SIMVASTATIN SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 A211394-004 SIMVASTATIN SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27
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 2026-02-19 14:30 UTC 2026-02 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211394-001 SIMVASTATIN 10MG TABLET / ORAL AB 2024-11-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211394-002 SIMVASTATIN 20MG TABLET / ORAL AB 2024-11-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211394-003 SIMVASTATIN 40MG TABLET / ORAL AB 2024-11-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211394-004 SIMVASTATIN 80MG TABLET / ORAL AB 2024-11-27 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Simvastatin SIMVASTATIN Westminster Pharmaceuticals, LLC acaaab63-c9ff-44c9-8fde-9a4ea6454dd7 2025-04-21 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211394 application number: ANDA211394