Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075027
Company: PADAGIS US
Company: PADAGIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | GEL;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 |
---|---|---|---|---|---|---|---|
10/31/1997 | 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 |
---|---|---|---|---|---|
11/28/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
12/20/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
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12/20/2000 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/24/2000 | SUPPL-2 | Labeling |
Label is not available on this site. |
CLOBETASOL PROPIONATE
GEL;TOPICAL; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 075368 | FOUGERA PHARMS |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 075027 | PADAGIS US |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 075279 | TARO |