Product NDC: | 0007-4885 |
Proprietary Name: | REQUIP |
Non Proprietary Name: | ropinirole hydrochloride |
Active Ingredient(s): | 2 mg/1 & nbsp; ropinirole hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0007-4885 |
Labeler Name: | GlaxoSmithKline LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022008 |
Marketing Category: | NDA |
Start Marketing Date: | 20080630 |
Package NDC: | 0007-4885-13 |
Package Description: | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0007-4885-13) |
NDC Code | 0007-4885-13 |
Proprietary Name | REQUIP |
Package Description | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0007-4885-13) |
Product NDC | 0007-4885 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | ropinirole hydrochloride |
Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20080630 |
Marketing Category Name | NDA |
Labeler Name | GlaxoSmithKline LLC |
Substance Name | ROPINIROLE HYDROCHLORIDE |
Strength Number | 2 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC] |