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 4 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 2019-12-13 00:20 UTC 2019-12 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020740-005 BAYCOL 0.4MG TABLET / ORAL 1999-05-24 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020740-006 BAYCOL 0.8MG TABLET / ORAL 2000-07-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020740-001 BAYCOL 0.05MG TABLET / ORAL 1997-06-26 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020740-002 BAYCOL 0.1MG TABLET / ORAL 1997-06-26 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020740-003 BAYCOL 0.2MG TABLET / ORAL 1997-06-26 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N020740-004 BAYCOL 0.3MG TABLET / ORAL 1997-06-26 c0c555d07b60…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.