Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210162
Company: MYLAN TECH VIATRIS
Company: MYLAN TECH VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUPRENORPHINE | BUPRENORPHINE | 5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| BUPRENORPHINE | BUPRENORPHINE | 7.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| BUPRENORPHINE | BUPRENORPHINE | 10MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| BUPRENORPHINE | BUPRENORPHINE | 15MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| BUPRENORPHINE | BUPRENORPHINE | 20MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 05/03/2021 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/14/2025 | SUPPL-3 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert, Labeling |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-2 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 03/14/2025 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |