Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215110
Company: ABBVIE INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAVYRET GLECAPREVIR; PIBRENTASVIR 50MG;20MG/PACKET PELLETS;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
06/10/2021 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215110s000,209394s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215110Orig1s000; 209394Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215110Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/28/2021 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215110Orig1s001;209394Orig1s014ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/28/2021 SUPPL-1 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf
09/28/2021 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209394s014,215110s001lbl.pdf
06/10/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215110s000,209394s013lbl.pdf

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