Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020680
Company: ABBOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORVIR RITONAVIR 100MG CAPSULE;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/01/1996 ORIG-1 Approval Type 3 - New Dosage Form 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
04/09/1999 SUPPL-14 Labeling

Label is not available on this site.

04/12/1999 SUPPL-13 Labeling

Label is not available on this site.

04/29/1999 SUPPL-12 Labeling

Label is not available on this site.

05/26/1999 SUPPL-11 Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020659s013_020680s011_Norvir.cfm
02/12/1998 SUPPL-10 Labeling

Label is not available on this site.

05/21/1998 SUPPL-9 Manufacturing (CMC)-Packaging Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020680_S009_NORVIR.pdf
10/31/1997 SUPPL-8 Labeling

Label is not available on this site.

09/12/1997 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/11/1997 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/08/1997 SUPPL-5 Labeling

Label is not available on this site.

09/24/1996 SUPPL-4 Labeling

Label is not available on this site.

10/01/1996 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1996 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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