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