Home Applications 020740 Application 020740
Type NDA
Sponsor BAYER PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BAYCOL CERIVASTATIN SODIUM TABLET;ORAL 0.05MG No No 002 BAYCOL CERIVASTATIN SODIUM TABLET;ORAL 0.1MG No No 003 BAYCOL CERIVASTATIN SODIUM TABLET;ORAL 0.2MG No No 004 BAYCOL CERIVASTATIN SODIUM TABLET;ORAL 0.3MG No No 005 BAYCOL CERIVASTATIN SODIUM TABLET;ORAL 0.4MG No No 006 BAYCOL CERIVASTATIN SODIUM TABLET;ORAL 0.8MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020740-001 BAYCOL CERIVASTATIN SODIUM 0.05MG TABLET / ORAL 1997-06-26 N020740-002 BAYCOL CERIVASTATIN SODIUM 0.1MG TABLET / ORAL 1997-06-26 N020740-003 BAYCOL CERIVASTATIN SODIUM 0.2MG TABLET / ORAL 1997-06-26 N020740-004 BAYCOL CERIVASTATIN SODIUM 0.3MG TABLET / ORAL 1997-06-26 N020740-005 BAYCOL CERIVASTATIN SODIUM 0.4MG TABLET / ORAL 1999-05-24 N020740-006 BAYCOL CERIVASTATIN SODIUM 0.8MG TABLET / ORAL 2000-07-24
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 2 of 7 · 264 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 2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 79d66fd596c7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.