Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202577
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FENTANYL FENTANYL 100MCG TABLET;BUCCAL None (Tentative Approval) None No No
FENTANYL FENTANYL 200MCG TABLET;BUCCAL None (Tentative Approval) None No No
FENTANYL FENTANYL 300MCG TABLET;BUCCAL None (Tentative Approval) None No No
FENTANYL FENTANYL 400MCG TABLET;BUCCAL None (Tentative Approval) None No No
FENTANYL FENTANYL 600MCG TABLET;BUCCAL None (Tentative Approval) None No No
FENTANYL FENTANYL 800MCG TABLET;BUCCAL 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
03/04/2015 ORIG-1 Tentative Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202577Orig1s000TA_ltr.pdf

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