Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202577
Company: MYLAN PHARMS INC
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)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202577Orig1s000TA_ltr.pdf |