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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 206614

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NDA 206614 describes RITONAVIR, which is a drug marketed by Amneal Pharms Llc, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, and Hikma, and is included in four 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. Nine suppliers are listed for this compound. Additional details are available on the ritonavir profile page.
Summary for 206614
Applicant:Aurobindo Pharma Ltd
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206614
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RITONAVIR ritonavir TABLET;ORAL 206614 ANDA American Health Packaging 60687-420 60687-420-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-420-25) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-420-95)
RITONAVIR ritonavir TABLET;ORAL 206614 ANDA Aurobindo Pharma Limited 65862-687 65862-687-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-687-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 17, 2018TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson

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