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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207154
Company: ALMIRALL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACZONE DAPSONE 7.5% GEL;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
02/24/2016 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207154s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207154Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207154Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/10/2019 SUPPL-4 Efficacy-New Patient Population, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207154s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207154Orig1s004ltr.pdf
05/18/2018 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207154s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207154Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/10/2019 SUPPL-4 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207154s004lbl.pdf
09/10/2019 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207154s004lbl.pdf
05/18/2018 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207154s003lbl.pdf
02/24/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207154s000lbl.pdf

ACZONE

GEL;TOPICAL; 7.5%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACZONE DAPSONE 7.5% GEL;TOPICAL Prescription Yes AB 207154 ALMIRALL
DAPSONE DAPSONE 7.5% GEL;TOPICAL Prescription No AB 213847 MYLAN
DAPSONE DAPSONE 7.5% GEL;TOPICAL Prescription No AB 210191 TARO PHARMS
DAPSONE DAPSONE 7.5% GEL;TOPICAL Prescription No AB 214722 TORRENT
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