Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 209512
Company: ABBVIE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NORVIR RITONAVIR 100MG/PACKET POWDER;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
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
08/21/2019 SUPPL-5 Labeling-Patient Package Insert, Labeling-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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/21/2019 SUPPL-5 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020659s070,022417s022,209512s005lbl.pdf
08/21/2019 SUPPL-5 Labeling-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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