Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021316
Company: COVIS
Company: COVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALTOPREV | LOVASTATIN | 10MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| ALTOPREV | LOVASTATIN | 20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| ALTOPREV | LOVASTATIN | 40MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| ALTOPREV | LOVASTATIN | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/26/2002 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21316ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021316_altocor.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/14/2024 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021316s037lbl.pdf | |
| 09/25/2020 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021316s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021316Orig1s036ltr.pdf | |
| 02/28/2018 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021316s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021316Orig1s035ltr.pdf | |
| 08/04/2017 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021316s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021316Orig1s034ltr.pdf | |
| 09/14/2015 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/2015 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/2014 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021316s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021316Orig1s031ltr.pdf | |
| 05/15/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/2012 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021316Orig1s029ltr.pdf | |
| 12/21/2012 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021316Orig1s028ltr.pdf | |
| 04/26/2012 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021316s026ltr.pdf | |
| 02/01/2007 | SUPPL-18 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021316s018ltr.pdf |
| 07/21/2004 | SUPPL-10 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21316s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21316s010ltr.pdf | |
| 09/24/2003 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21316slr006_lovastatin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21316slr006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021316_S006_ALTOCAR_TABLETS_AP.pdf | |
| 08/20/2003 | SUPPL-5 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21316slr005ltr.pdf |
| 12/18/2002 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/2002 | SUPPL-1 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21316se1-001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021316_S001_ALTOCOR_AP.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/14/2024 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021316s037lbl.pdf | |
| 09/25/2020 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021316s036lbl.pdf | |
| 02/28/2018 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021316s035lbl.pdf | |
| 08/04/2017 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021316s034lbl.pdf | |
| 04/30/2014 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021316s031lbl.pdf | |
| 12/21/2012 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s028lbl.pdf | |
| 10/31/2012 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s029lbl.pdf | |
| 04/26/2012 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021316s026lbl.pdf | |
| 07/21/2004 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21316s010lbl.pdf | |
| 09/24/2003 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21316slr006_lovastatin_lbl.pdf | |
| 09/11/2002 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316s1lbl.pdf | |
| 06/26/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21316lbl.pdf |