Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072538
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 | LOTION;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 |
---|---|---|---|---|---|---|---|
01/31/1990 | 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 |
---|---|---|---|---|---|
01/28/2013 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
12/16/1997 | SUPPL-5 | Labeling |
Label is not available on this site. |
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01/24/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
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05/05/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
BETAMETHASONE DIPROPIONATE
LOTION;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 | LOTION;TOPICAL | Prescription | No | AB | 071467 | COSETTE |
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | LOTION;TOPICAL | Prescription | No | AB | 070275 | FOUGERA PHARMS INC |
BETAMETHASONE DIPROPIONATE | BETAMETHASONE DIPROPIONATE | EQ 0.05% BASE | LOTION;TOPICAL | Prescription | No | AB | 072538 | PADAGIS US |