Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206986
Company: ALVOGEN
Company: ALVOGEN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | 10MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | No | Yes |
HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | 15MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | 20MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | 30MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | 40MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | None | No | No |
HYDROCODONE BITARTRATE | HYDROCODONE BITARTRATE | 50MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
01/21/2020 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
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Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206986Orig1s000ltr.pdf |