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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207407
Company: LANNETT CO INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOPINAVIR AND RITONAVIR LOPINAVIR; RITONAVIR 80MG/ML;20MG/ML SOLUTION;ORAL Prescription AA 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
12/27/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207407Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207407Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/27/2020 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/27/2020 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/27/2020 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/27/2020 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/27/2020 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/27/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207407Orig1s000lbl.pdf

LOPINAVIR AND RITONAVIR

SOLUTION;ORAL; 80MG/ML;20MG/ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
KALETRA LOPINAVIR; RITONAVIR 80MG/ML;20MG/ML SOLUTION;ORAL Prescription Yes AA 021251 ABBVIE
LOPINAVIR AND RITONAVIR LOPINAVIR; RITONAVIR 80MG/ML;20MG/ML SOLUTION;ORAL Prescription No AA 207407 LANNETT CO INC
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