Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075633
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE (EMOLLIENT) | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | AB2 | 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 |
---|---|---|---|---|---|---|---|
05/17/2000 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2000/075633_approval_package.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/14/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
10/02/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/24/2001 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
CLOBETASOL PROPIONATE (EMOLLIENT)
CREAM;TOPICAL; 0.05%
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE (EMOLLIENT) | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 075430 | FOUGERA PHARMS |
CLOBETASOL PROPIONATE (EMOLLIENT) | CLOBETASOL PROPIONATE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 075633 | TARO |