Application 020740

Type
NDA
Sponsor
BAYER PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BAYCOLCERIVASTATIN SODIUMTABLET;ORAL0.05MGNoNo
002BAYCOLCERIVASTATIN SODIUMTABLET;ORAL0.1MGNoNo
003BAYCOLCERIVASTATIN SODIUMTABLET;ORAL0.2MGNoNo
004BAYCOLCERIVASTATIN SODIUMTABLET;ORAL0.3MGNoNo
005BAYCOLCERIVASTATIN SODIUMTABLET;ORAL0.4MGNoNo
006BAYCOLCERIVASTATIN SODIUMTABLET;ORAL0.8MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020740-001BAYCOLCERIVASTATIN SODIUM0.05MGTABLET / ORAL1997-06-26
N020740-002BAYCOLCERIVASTATIN SODIUM0.1MGTABLET / ORAL1997-06-26
N020740-003BAYCOLCERIVASTATIN SODIUM0.2MGTABLET / ORAL1997-06-26
N020740-004BAYCOLCERIVASTATIN SODIUM0.3MGTABLET / ORAL1997-06-26
N020740-005BAYCOLCERIVASTATIN SODIUM0.4MGTABLET / ORAL1999-05-24
N020740-006BAYCOLCERIVASTATIN SODIUM0.8MGTABLET / ORAL2000-07-24

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 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020740-001BAYCOL0.05MGTABLET / ORAL1997-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020740-002BAYCOL0.1MGTABLET / ORAL1997-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020740-003BAYCOL0.2MGTABLET / ORAL1997-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020740-004BAYCOL0.3MGTABLET / ORAL1997-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020740-005BAYCOL0.4MGTABLET / ORAL1999-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020740-006BAYCOL0.8MGTABLET / ORAL2000-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020740-001BAYCOL0.05MGTABLET / ORAL1997-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020740-002BAYCOL0.1MGTABLET / ORAL1997-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020740-003BAYCOL0.2MGTABLET / ORAL1997-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020740-004BAYCOL0.3MGTABLET / ORAL1997-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020740-005BAYCOL0.4MGTABLET / ORAL1999-05-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020740-006BAYCOL0.8MGTABLET / ORAL2000-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020740-001BAYCOL0.05MGTABLET / ORAL1997-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020740-002BAYCOL0.1MGTABLET / ORAL1997-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020740-003BAYCOL0.2MGTABLET / ORAL1997-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020740-004BAYCOL0.3MGTABLET / ORAL1997-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020740-005BAYCOL0.4MGTABLET / ORAL1999-05-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020740-006BAYCOL0.8MGTABLET / ORAL2000-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020740-001BAYCOL0.05MGTABLET / ORAL1997-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020740-002BAYCOL0.1MGTABLET / ORAL1997-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020740-003BAYCOL0.2MGTABLET / ORAL1997-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020740-004BAYCOL0.3MGTABLET / ORAL1997-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020740-005BAYCOL0.4MGTABLET / ORAL1999-05-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020740-006BAYCOL0.8MGTABLET / ORAL2000-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020740-001BAYCOL0.05MGTABLET / ORAL1997-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020740-002BAYCOL0.1MGTABLET / ORAL1997-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020740-003BAYCOL0.2MGTABLET / ORAL1997-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020740-004BAYCOL0.3MGTABLET / ORAL1997-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020740-005BAYCOL0.4MGTABLET / ORAL1999-05-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020740-006BAYCOL0.8MGTABLET / ORAL2000-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020740-001BAYCOL0.05MGTABLET / ORAL1997-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020740-002BAYCOL0.1MGTABLET / ORAL1997-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020740-003BAYCOL0.2MGTABLET / ORAL1997-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020740-004BAYCOL0.3MGTABLET / ORAL1997-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020740-005BAYCOL0.4MGTABLET / ORAL1999-05-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020740-006BAYCOL0.8MGTABLET / ORAL2000-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020740-001BAYCOL0.05MGTABLET / ORAL1997-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020740-002BAYCOL0.1MGTABLET / ORAL1997-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020740-003BAYCOL0.2MGTABLET / ORAL1997-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020740-004BAYCOL0.3MGTABLET / ORAL1997-06-262680178bc6a6…

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13316ORIG2010-03-02
20891SUPPL2008-02-19
41631SUPPL2007-09-24
41630SUPPL2007-09-24
20889SUPPL2007-09-24
35251SUPPL2003-04-22
35252SUPPL2002-04-23
41634SUPPL2001-12-03
41633SUPPL2001-12-03
41628SUPPL2001-12-03
20890SUPPL2001-12-03
41632SUPPL2001-11-29
41629SUPPL2001-11-29
20888SUPPL2001-11-29
20887SUPPL2001-11-29
35250SUPPL2001-03-30
25666SUPPL2001-03-30
3236SUPPL2000-07-23
3235SUPPL2000-07-23
13318SUPPL2000-07-21
13317SUPPL2000-07-21
25665SUPPL1999-05-24