U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075633
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
Back to Top