Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076477
Company: SUN PHARM INDS LTD

Products on ANDA 076477

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 10MG BASE	TABLET;ORAL	Discontinued	None	No	No
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 20MG BASE	TABLET;ORAL	Discontinued	None	No	No
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 40MG BASE	TABLET;ORAL	Discontinued	None	No	No
ATORVASTATIN CALCIUM	ATORVASTATIN CALCIUM	EQ 80MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076477

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/30/2011	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/076477Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/076477Orig1s000.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/04/2024	SUPPL-33	Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/15/2023	SUPPL-31	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
06/08/2021	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
06/08/2021	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
06/08/2021	SUPPL-23	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
06/08/2021	SUPPL-17	Labeling-Patient Package Insert, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
06/08/2021	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
06/08/2021	SUPPL-12	Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
06/08/2021	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
10/06/2015	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/23/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/27/2013	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/20/2012	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/17/2012	SUPPL-1	Labeling-Package Insert		Label is not available on this site.