Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020680
Company: ABBOTT

Products on NDA 020680

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORVIR	RITONAVIR	100MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020680

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.html
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.