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)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206986Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/31/2024 | SUPPL-7 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2023 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |