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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209512
Company: ABBVIE

Products on NDA 209512

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NORVIR	RITONAVIR	100MG/PACKET	POWDER;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209512

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/07/2017	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209512Orig1s000Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209512Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2022	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022417Orig1s025,020659Orig1s073,209512Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022417Orig1s025;020659Orig1s073;209512Orig1s008ltr.pdf
10/21/2020	SUPPL-7	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020659s072,022417s024,209512s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020659Orig1s072, 022417Orig1s024, 209512Orig1s007ltr.pdf
12/19/2019	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s071, 209512s006, 022417s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020659Orig1s071, 209512Orig1s006, 022417Orig1s023ltr.pdf
08/21/2019	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s070,022417s022,209512s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020659Orig1s070, 209512Orig1s005, 022417Orig1s022ltr.pdf
11/15/2018	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209512s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020659Orig1s069,022417Orig1s021,0209512Orig1s004ltr.pdf
09/29/2017	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209512Orig1s002,022417Origs020,020659Orig1s068ltr.pdf
06/29/2017	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020659s066,022417s018,209512s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020659Orig1s066,022417Orig1s018,209512Orig1s001ltr.pdf

Labels for NDA 209512

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2022	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022417Orig1s025,020659Orig1s073,209512Orig1s008lbl.pdf
10/21/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020659s072,022417s024,209512s007lbl.pdf
10/21/2020	SUPPL-7	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020659s072,022417s024,209512s007lbl.pdf
12/19/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s071, 209512s006, 022417s023lbl.pdf
12/19/2019	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s071, 209512s006, 022417s023lbl.pdf
08/21/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s070,022417s022,209512s005lbl.pdf
08/21/2019	SUPPL-5	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s070,022417s022,209512s005lbl.pdf
11/15/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209512s004lbl.pdf
09/29/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf
09/29/2017	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512s002,022417s020,020659s068lbl.pdf
06/29/2017	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020659s066,022417s018,209512s001lbl.pdf
06/29/2017	SUPPL-1	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020659s066,022417s018,209512s001lbl.pdf
06/07/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209512lbl.pdf

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