Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075279
Company: TARO
Company: TARO
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 |
---|---|---|---|---|---|---|---|
05/28/1999 | ORIG-1 | Approval |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75279ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/075279_clobetasol_toc.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/06/2019 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
12/09/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/09/2002 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/11/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/23/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
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 |