Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209655
Company: ZYDUS PHARMS
Company: ZYDUS PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FENTANYL-100 | FENTANYL | 100MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| FENTANYL-12 | FENTANYL | 12.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| FENTANYL-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| FENTANYL-37 | FENTANYL | 37.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| FENTANYL-62 | FENTANYL | 62.5MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| FENTANYL-75 | FENTANYL | 75MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
| FENTANYL-87 | FENTANYL | 87.5MCG/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 |
|---|---|---|---|---|---|---|---|
| 01/24/2023 | 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 |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-2 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-1 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |