Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076592
Company: PADAGIS ISRAEL
Company: PADAGIS ISRAEL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | CREAM, AUGMENTED;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
12/09/2003 | 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 |
---|---|---|---|---|---|
08/25/2020 | SUPPL-7 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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08/25/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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09/28/2009 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
BETAMETHASONE DIPROPIONATE
CREAM, AUGMENTED;TOPICAL; EQ 0.05% BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | CREAM, AUGMENTED;TOPICAL | Prescription | No | AB | 076215 | FOUGERA PHARMS |
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | CREAM, AUGMENTED;TOPICAL | Prescription | No | AB | 078930 | GLENMARK PHARMS INC |
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | CREAM, AUGMENTED;TOPICAL | Prescription | No | AB | 076592 | PADAGIS ISRAEL |
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | CREAM, AUGMENTED;TOPICAL | Prescription | No | AB | 076543 | TARO |