Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200156
Company: WATSON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARMODAFINIL ARMODAFINIL 50MG TABLET; ORAL None (Tentative Approval) None No No
ARMODAFINIL ARMODAFINIL 100MG TABLET;ORAL Discontinued None No No
ARMODAFINIL ARMODAFINIL 150MG TABLET; ORAL None (Tentative Approval) None No No
ARMODAFINIL ARMODAFINIL 200MG TABLET;ORAL Discontinued None No No
ARMODAFINIL ARMODAFINIL 2500MG 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
08/29/2012 ORIG-2 Tentative Approval Not Applicable

Label is not available on this site.

08/29/2012 ORIG-1 Approval Not Applicable Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200156Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/25/2017 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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