Product NDC: | 0781-5788 |
Proprietary Name: | ropinirole |
Non Proprietary Name: | ropinirole |
Active Ingredient(s): | 12 mg/1 & nbsp; ropinirole |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0781-5788 |
Labeler Name: | Sandoz Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA201047 |
Marketing Category: | ANDA |
Start Marketing Date: | 20120606 |
Package NDC: | 0781-5788-92 |
Package Description: | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5788-92) |
NDC Code | 0781-5788-92 |
Proprietary Name | ropinirole |
Package Description | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0781-5788-92) |
Product NDC | 0781-5788 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | ropinirole |
Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20120606 |
Marketing Category Name | ANDA |
Labeler Name | Sandoz Inc |
Substance Name | ROPINIROLE HYDROCHLORIDE |
Strength Number | 12 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |