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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020629
Company: MYLAN

Products on NDA 020629

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DENAVIR	PENCICLOVIR	1%	CREAM;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020629

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.

Labels for NDA 020629

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

Therapeutic Equivalents for NDA 020629

DENAVIR

CREAM;TOPICAL; 1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DENAVIR	PENCICLOVIR	1%	CREAM;TOPICAL	Prescription	Yes	AB	020629	MYLAN
PENCICLOVIR	PENCICLOVIR	1%	CREAM;TOPICAL	Prescription	No	AB	212710	TEVA PHARMS USA
PENCICLOVIR	PENCICLOVIR	1%	CREAM;TOPICAL	Prescription	No	AB	216981	TORRENT

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