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 43 .
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 1 of 7 · 258 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 2026-09-14 22:38:34 2026-08 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 fd3edfee7708…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…