Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075368
Company: FOUGERA PHARMS
Company: FOUGERA PHARMS
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 | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/15/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75368ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/14/2006 | 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 |