Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206118
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | OINTMENT, AUGMENTED;TOPICAL | 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 |
---|---|---|---|---|---|---|---|
11/09/2017 | 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 |
---|---|---|---|---|---|
04/17/2020 | SUPPL-2 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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04/17/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |