Details for New Drug Application (NDA): 208890

NDA 208890 describes RITONAVIR, which is a drug marketed by Hikma, Norvium Bioscience, Amneal, Aurobindo Pharma Ltd, Cipla, and Hetero Labs Ltd Iii, and is included in seven NDAs. It is available from six suppliers. Additional details are available on the RITONAVIR profile page.

The generic ingredient in RITONAVIR is ritonavir. There are twenty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ritonavir profile page.

Summary for 208890

Tradename:	RITONAVIR
Applicant:	Amneal
Ingredient:	ritonavir
Patents:	0

Pharmacology for NDA: 208890

Mechanism of Action

Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors P-Glycoprotein Inhibitors UDP Glucuronosyltransferases Inducers

Medical Subject Heading (MeSH) Categories for 208890

Cytochrome P-450 CYP3A Inhibitors

HIV Protease Inhibitors

Suppliers and Packaging for NDA: 208890

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RITONAVIR	ritonavir	TABLET;ORAL	208890	ANDA	Amneal Pharmaceuticals LLC	65162-061	65162-061-06	60 TABLET in 1 BOTTLE (65162-061-06)
RITONAVIR	ritonavir	TABLET;ORAL	208890	ANDA	Amneal Pharmaceuticals LLC	65162-061	65162-061-32	360 TABLET in 1 BOTTLE (65162-061-32)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Sep 17, 2018	TE:	AB	RLD:	No

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