Product NDC: | 13811-639 |
Proprietary Name: | Ropinirole |
Non Proprietary Name: | Ropinirole |
Active Ingredient(s): | 2 mg/1 & nbsp; Ropinirole |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 13811-639 |
Labeler Name: | Trigen Laboratories, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA202786 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130615 |
Package NDC: | 13811-639-30 |
Package Description: | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13811-639-30) |
NDC Code | 13811-639-30 |
Proprietary Name | Ropinirole |
Package Description | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (13811-639-30) |
Product NDC | 13811-639 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Ropinirole |
Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20130615 |
Marketing Category Name | ANDA |
Labeler Name | Trigen Laboratories, Inc. |
Substance Name | ROPINIROLE HYDROCHLORIDE |
Strength Number | 2 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |