Janssen Pharmaceutica NV

Overview

Janssen Pharmaceutica NV is a pharmaceutical company that operates as a subsidiary of Johnson & Johnson. The company is involved in the development and marketing of prescription drugs across multiple therapeutic areas. Janssen is renowned for its innovative research and commitment to improving global health.

Therapeutic areas

API / Drug Master Files

Janssen Pharmaceutica NV holds 14 active (77 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• RILPIVIRINE DRUG SUBSTANCEActive2019-04-22
• RILPIVIRINE HYDROCHLORIDE (R314585) DRUG SUBSTANCEActive2010-07-19
• PALIPERIDONE PALMITATE (R092670) DRUG SUBSTANCEActive2007-10-24
• ETRAVIRINE (R165335) DRUG SUBSTANCEActive2007-04-18
• PALIPERIDONE (R076477) DRUG SUBSTANCEActive2005-11-29
• DARUNAVIR (R319064) DRUG SUBSTANCEActive2005-11-02
• RISPERIDONE (R064766) DRUG SUBSTANCEActive1995-04-11
• HALOPERIDOL DECANOATEActive1994-06-23
• HALOPERIDOL (R001625) DRUG SUBSTANCEActive1994-06-13
• INTERMEDIATE T000263Active1994-06-13
• TOPIRAMATE DRUG SUBSTANCEActive1994-05-27
• INTERMEDIATE T000034Active1994-03-04
• ITRACONAZOLE (R051211) DRUG SUBSTANCEActive1994-02-18
• KETOCONAZOLE DRUG SUBSTANCEActive1993-01-15
• SIMEPREVIR (R494617) DRUG SUBSTANCEInactive2013-03-22

Showing 15 of 77 Drug Master Files.

FDA compliance signals