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CLOBETASOL PROPIONATE از شرکت TARO

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CLOBETASOL PROPIONATE از شرکت TARO

Abbreviated New Drug Application (ANDA): 075224

Company: TARO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription

AT

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
11/16/1998 ORIG-1 Approval

Letter (PDF)

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75224ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75-224_Clobetasol.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/06/2017 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/16/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

12/16/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/09/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

CLOBETASOL PROPIONATE

SOLUTION;TOPICAL; 0.05%

TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 212881 ALEOR DERMACEUTICALS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 074331 COSETTE
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 075391 FOUGERA PHARMS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 210190 GLENMARK PHARMS LTD
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 209361 MACLEODS PHARMS LTD
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 206075 NOVEL LABS INC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 213139 PRINSTON INC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 211494 SAPTALIS PHARMS
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 075224 TARO
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 075363 TARO
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 076977 TOLMAR
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 075205 WOCKHARDT BIO AG
EMBELINE CLOBETASOL PROPIONATE 0.05% SOLUTION;TOPICAL Prescription No AT 074222 AKORN
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