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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021316
Company: COVIS

Products on NDA 021316

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021316

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

Labels for NDA 021316

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

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