Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078773
Company: TEVA PHARMS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/29/2012 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/078773s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/078773Orig1s000.pdf

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