Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091677
Company: HETERO LABS LTD III

Products on ANDA 091677

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 091677

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/04/2021	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/091677Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 091677

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

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