Stivarga - 50419-171-03 - (regorafenib)

Alphabetical Index


Drug Information of Stivarga

Product NDC: 50419-171
Proprietary Name: Stivarga
Non Proprietary Name: regorafenib
Active Ingredient(s): 40    mg/1 & nbsp;   regorafenib
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Stivarga

Product NDC: 50419-171
Labeler Name: Bayer HealthCare Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA203085
Marketing Category: NDA
Start Marketing Date: 20120927

Package Information of Stivarga

Package NDC: 50419-171-03
Package Description: 3 BOTTLE, PLASTIC in 1 BOX (50419-171-03) > 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01)

NDC Information of Stivarga

NDC Code 50419-171-03
Proprietary Name Stivarga
Package Description 3 BOTTLE, PLASTIC in 1 BOX (50419-171-03) > 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50419-171-01)
Product NDC 50419-171
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name regorafenib
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20120927
Marketing Category Name NDA
Labeler Name Bayer HealthCare Pharmaceuticals Inc.
Substance Name REGORAFENIB MONOHYDRATE
Strength Number 40
Strength Unit mg/1
Pharmaceutical Classes

Complete Information of Stivarga


General Information