Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021535
Company: GALDERMA LABS LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CLOBEX CLOBETASOL PROPIONATE 0.05% LOTION;TOPICAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/24/2003 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21535_clobex_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21535ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-535_Clobex.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/30/2012 SUPPL-3 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535Orig1s003, 021644Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021535Orig1s003,021644Orig1s003ltr.pdf
08/17/2012 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021535Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/30/2012 SUPPL-3 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535Orig1s003, 021644Orig1s003lbl.pdf
08/17/2012 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535s002lbl.pdf
07/24/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21535_clobex_lbl.pdf

CLOBEX

LOTION;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% LOTION;TOPICAL Prescription No AB 078223 ACTAVIS MID ATLANTIC
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% LOTION;TOPICAL Prescription No AB 205249 CADILA
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% LOTION;TOPICAL Prescription No AB 209147 LUPIN LTD
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% LOTION;TOPICAL Prescription No AB 200302 TARO
CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE 0.05% LOTION;TOPICAL Prescription No AB 208667 TELIGENT
CLOBEX CLOBETASOL PROPIONATE 0.05% LOTION;TOPICAL Prescription Yes AB 021535 GALDERMA LABS LP

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