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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020705
Company: VIIV HLTHCARE

Products on NDA 020705

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RESCRIPTOR	DELAVIRDINE MESYLATE	100MG	TABLET;ORAL	Discontinued	None	Yes	No
RESCRIPTOR	DELAVIRDINE MESYLATE	200MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020705

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/04/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/10/2012	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020705s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020705Orig1s018ltr.pdf
04/07/2006	SUPPL-10	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020705s010ltr.pdf
03/14/2002	SUPPL-9	Labeling	Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20705s9ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020705_S009_Rescriptor Tablets_APPROVAL PACKAGE.pdf
05/16/2001	SUPPL-8	Efficacy-Accelerated Approval	Label (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20705S8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020705_S008_RescriptorTOC.cfm
08/16/1999	SUPPL-4	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020705_S004_Rescriptor Tablets_APPROVAL PACKAGE.pdf
07/14/1999	SUPPL-3	Manufacturing (CMC)-Formulation	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20705s03lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20705s03ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-705S003.pdf
10/23/1998	SUPPL-2	Manufacturing (CMC)	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020705_S002_Rescriptor Tablets_APPROVAL PACKAGE.pdf
02/11/1998	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020705

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/10/2012	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020705s018lbl.pdf
05/16/2001	SUPPL-8	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20705S8lbl.pdf
07/14/1999	SUPPL-3	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20705s03lbl.pdf

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