Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020705
Company: VIIV HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RESCRIPTOR DELAVIRDINE MESYLATE 100MG TABLET;ORAL Prescription None Yes No
RESCRIPTOR DELAVIRDINE MESYLATE 200MG TABLET;ORAL 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
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.

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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