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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204587
Company: HETERO LABS LTD III

Products on ANDA 204587

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204587

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/2018	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 204587

RITONAVIR

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NORVIR	RITONAVIR	100MG	TABLET;ORAL	Prescription	Yes	AB	022417	ABBVIE
RITONAVIR	RITONAVIR	100MG	TABLET;ORAL	Prescription	No	AB	208890	AMNEAL
RITONAVIR	RITONAVIR	100MG	TABLET;ORAL	Prescription	No	AB	206614	AUROBINDO PHARMA LTD
RITONAVIR	RITONAVIR	100MG	TABLET;ORAL	Prescription	No	AB	202573	CIPLA
RITONAVIR	RITONAVIR	100MG	TABLET;ORAL	Prescription	No	AB	203759	CIPLA
RITONAVIR	RITONAVIR	100MG	TABLET;ORAL	Prescription	No	AB	204587	HETERO LABS LTD III

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