اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BAYCOL از شرکت BAYER PHARMS
New Drug Application (NDA): 020740
Company: BAYER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BAYCOL | CERIVASTATIN SODIUM | 0.05MG | TABLET;ORAL | Discontinued |
None |
No | No |
| BAYCOL | CERIVASTATIN SODIUM | 0.1MG | TABLET;ORAL | Discontinued |
None |
No | No |
| BAYCOL | CERIVASTATIN SODIUM | 0.2MG | TABLET;ORAL | Discontinued |
None |
No | No |
| BAYCOL | CERIVASTATIN SODIUM | 0.3MG | TABLET;ORAL | Discontinued |
None |
No | No |
| BAYCOL | CERIVASTATIN SODIUM | 0.4MG | TABLET;ORAL | Discontinued |
None |
No | No |
| BAYCOL | CERIVASTATIN SODIUM | 0.8MG | TABLET;ORAL | Discontinued |
None |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/26/1997 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020740_baycol_toc.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/21/2001 | SUPPL-19 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S19lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S019_Baycol.pdf |
||
| 05/10/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S018_Baycol.pdf |
||
| 02/27/2001 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/2001 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020740_S016_BAYCOL_TABLETS.pdf |
|
| 11/06/2000 | SUPPL-14 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S014_Baycol.pdf |
|
| 07/21/2000 | SUPPL-13 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20740S8,13LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol.cfm |
||
| 07/03/2000 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020740_S012_BAYCOL.pdf |
|
| 12/22/1999 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020740_S010_BAYCOL.pdf |
|
| 07/21/2000 | SUPPL-8 | Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20740S8,13LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol.cfm |
||
| 12/10/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020740s007.pdf |
|
| 03/30/2001 | SUPPL-6 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S6lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20740S6ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-740S006_Baycol.pdf |
||
| 08/23/1999 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 07/13/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/04/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-740S003_Baycol.pdf |
|
| 05/24/1999 | SUPPL-2 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20740s02ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-740S002_Baycol.cfm |
|
| 08/20/1998 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/21/2001 | SUPPL-19 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S19lbl.pdf | |
| 05/10/2001 | SUPPL-18 |
Manufacturing (CMC)-Control |
Label (PDF) |
This supplement type does not usually require new labeling. |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S18lbl.pdf |
| 03/30/2001 | SUPPL-6 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20740S6lbl.pdf | |
| 07/21/2000 | SUPPL-13 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf | |
| 07/21/2000 | SUPPL-8 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-740S008_Baycol_prntlbl.pdf | |
| 06/26/1997 | ORIG-1 | Approval | https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020740_baycol_toc.cfm |
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