Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077051
Company: LAVIPHARM LABS
Company: LAVIPHARM LABS
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-25 | FENTANYL | 25MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
FENTANYL-50 | FENTANYL | 50MCG/HR | FILM, EXTENDED RELEASE;TRANSDERMAL | Discontinued | None | No | No |
FENTANYL-75 | FENTANYL | 75MCG/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 |
---|---|---|---|---|---|---|---|
08/04/2006 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/15/2010 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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01/09/2008 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |