Drugs@FDA: FDA Approved Drug Products

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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
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
CLOBETASOL PROPIONATE (EMOLLIENT) CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB2 209411 TELIGENT PHARMA INC
EMBELINE E CLOBETASOL PROPIONATE 0.05% CREAM;TOPICAL Prescription No AB2 075325 HI TECH PHARMA

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