Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213857
Company: LAURUS

Products on ANDA 213857

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	100MG;25MG	TABLET;ORAL	Prescription	AB	No	No
LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	200MG;50MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213857

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/21/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213857

LOPINAVIR AND RITONAVIR

TABLET;ORAL; 100MG;25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KALETRA	LOPINAVIR; RITONAVIR	100MG;25MG	TABLET;ORAL	Prescription	Yes	AB	021906	ABBVIE
LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	100MG;25MG	TABLET;ORAL	Prescription	No	AB	091677	HETERO LABS LTD III
LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	100MG;25MG	TABLET;ORAL	Prescription	No	AB	213857	LAURUS
LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	100MG;25MG	TABLET;ORAL	Prescription	No	AB	079074	MYLAN LABS LTD

TABLET;ORAL; 200MG;50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KALETRA	LOPINAVIR; RITONAVIR	200MG;50MG	TABLET;ORAL	Prescription	Yes	AB	021906	ABBVIE
LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	200MG;50MG	TABLET;ORAL	Prescription	No	AB	091677	HETERO LABS LTD III
LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	200MG;50MG	TABLET;ORAL	Prescription	No	AB	213857	LAURUS
LOPINAVIR AND RITONAVIR	LOPINAVIR; RITONAVIR	200MG;50MG	TABLET;ORAL	Prescription	No	AB	079074	MYLAN LABS LTD