Kuvan - 68135-300-01 - (Sapropterin dihydrochloride)

Alphabetical Index


Drug Information of Kuvan

Product NDC: 68135-300
Proprietary Name: Kuvan
Non Proprietary Name: Sapropterin dihydrochloride
Active Ingredient(s): 100    mg/1 & nbsp;   Sapropterin dihydrochloride
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of Kuvan

Product NDC: 68135-300
Labeler Name: BioMarin Pharmaceutical Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA022181
Marketing Category: NDA
Start Marketing Date: 20071214

Package Information of Kuvan

Package NDC: 68135-300-01
Package Description: 30 TABLET in 1 BOTTLE (68135-300-01)

NDC Information of Kuvan

NDC Code 68135-300-01
Proprietary Name Kuvan
Package Description 30 TABLET in 1 BOTTLE (68135-300-01)
Product NDC 68135-300
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Sapropterin dihydrochloride
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 20071214
Marketing Category Name NDA
Labeler Name BioMarin Pharmaceutical Inc.
Substance Name SAPROPTERIN DIHYDROCHLORIDE
Strength Number 100
Strength Unit mg/1
Pharmaceutical Classes

Complete Information of Kuvan


General Information