Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202172
Company: WATSON LABS INC

Products on NDA 202172

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROSUVASTATIN ZINC	ROSUVASTATIN ZINC	5MG	TABLET; ORAL	None (Tentative Approval)	None	No	No
ROSUVASTATIN ZINC	ROSUVASTATIN ZINC	10MG	TABLET; ORAL	None (Tentative Approval)	None	No	No
ROSUVASTATIN ZINC	ROSUVASTATIN ZINC	20MG	TABLET; ORAL	None (Tentative Approval)	None	No	No
ROSUVASTATIN ZINC	ROSUVASTATIN ZINC	40MG	TABLET; ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202172

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/12/2016	ORIG-1	Tentative Approval	Type 2 - New Active Ingredient	STANDARD	Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202172s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202172Orig1s000TAltr.pdf