Product NDC: | 0078-0539 |
Proprietary Name: | Tyzeka |
Non Proprietary Name: | telbivudine |
Active Ingredient(s): | 20 mg/mL & nbsp; telbivudine |
Administration Route(s): | ORAL |
Dosage Form(s): | SOLUTION |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0078-0539 |
Labeler Name: | Novartis Pharmaceuticals Corporation |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022154 |
Marketing Category: | NDA |
Start Marketing Date: | 20090428 |
Package NDC: | 0078-0539-85 |
Package Description: | 300 mL in 1 BOTTLE (0078-0539-85) |
NDC Code | 0078-0539-85 |
Proprietary Name | Tyzeka |
Package Description | 300 mL in 1 BOTTLE (0078-0539-85) |
Product NDC | 0078-0539 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | telbivudine |
Dosage Form Name | SOLUTION |
Route Name | ORAL |
Start Marketing Date | 20090428 |
Marketing Category Name | NDA |
Labeler Name | Novartis Pharmaceuticals Corporation |
Substance Name | TELBIVUDINE |
Strength Number | 20 |
Strength Unit | mg/mL |
Pharmaceutical Classes | Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA] |