Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206952
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 10MG CAPSULE, EXTENDED RELEASE; ORAL None (Tentative Approval) None No No
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 15MG CAPSULE, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 20MG CAPSULE, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 30MG CAPSULE, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 40MG CAPSULE, EXTENDED RELEASE;ORAL None (Tentative Approval) None No No
HYDROCODONE BITARTRATE HYDROCODONE BITARTRATE 50MG CAPSULE, EXTENDED RELEASE;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
04/05/2017 ORIG-1 Tentative Approval STANDARD

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