Product NDC: | 0378-6046 |
Proprietary Name: | Risperidone |
Non Proprietary Name: | risperidone |
Active Ingredient(s): | 3 mg/1 & nbsp; risperidone |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, ORALLY DISINTEGRATING |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0378-6046 |
Labeler Name: | Mylan Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA091537 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130401 |
Package NDC: | 0378-6046-01 |
Package Description: | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-6046-01) |
NDC Code | 0378-6046-01 |
Proprietary Name | Risperidone |
Package Description | 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-6046-01) |
Product NDC | 0378-6046 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | risperidone |
Dosage Form Name | TABLET, ORALLY DISINTEGRATING |
Route Name | ORAL |
Start Marketing Date | 20130401 |
Marketing Category Name | ANDA |
Labeler Name | Mylan Pharmaceuticals Inc. |
Substance Name | RISPERIDONE |
Strength Number | 3 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Atypical Antipsychotic [EPC] |