Drugs@FDA: FDA Approved Drug Products

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

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