Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021316
Company: AZURITY
Company: AZURITY
| 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 | Discontinued | None | Yes | No |
| ALTOPREV | LOVASTATIN | 40MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| ALTOPREV | LOVASTATIN | 60MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| 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 |