Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206952
Company: ACTAVIS LABS FL INC
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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