Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079161
Company: STRIDES PHARMA

Products on ANDA 079161

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 5MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 10MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 20MG BASE	TABLET;ORAL	Discontinued	None	No	No
ROSUVASTATIN CALCIUM	ROSUVASTATIN CALCIUM	EQ 40MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 079161

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/19/2016	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079161s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079161Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/24/2024	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/26/2024	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/26/2024	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/26/2024	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/07/2020	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
04/07/2020	SUPPL-1	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.