Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020629
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DENAVIR PENCICLOVIR 1% CREAM;TOPICAL Prescription None 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
09/24/1996 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020629Orig1s000rev.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/21/2018 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020629s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020629Orig1s019ltr.pdf
02/09/2015 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

09/11/2013 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020629s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020629Orig1s016ltr.pdf
05/16/2003 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20629slr009_denavir_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20629slr009ltr.pdf
10/10/2003 SUPPL-8 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20629se5-008_denavir_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20629se5-008ltr.pdf
08/18/2001 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

12/22/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/22/1998 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/21/2018 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020629s019lbl.pdf
09/11/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020629s016lbl.pdf
10/10/2003 SUPPL-8 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20629se5-008_denavir_lbl.pdf
05/16/2003 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20629slr009_denavir_lbl.pdf

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