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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207407
Company: LANNETT CO INC

Products on ANDA 207407

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207407

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-Medication Guide, Labeling-Package Insert		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-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 207407

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

Therapeutic Equivalents for ANDA 207407

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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