| Product NDC: | 52584-107 |
| Proprietary Name: | Robinul |
| Non Proprietary Name: | Robinul |
| Active Ingredient(s): | .2 mg/mL & nbsp; Robinul |
| Administration Route(s): | INTRAMUSCULAR; INTRAVENOUS |
| Dosage Form(s): | INJECTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52584-107 |
| Labeler Name: | General Injectables & Vaccines, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA017558 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20121011 |
| Package NDC: | 52584-107-01 |
| Package Description: | 1 VIAL in 1 BAG (52584-107-01) > 20 mL in 1 VIAL |
| NDC Code | 52584-107-01 |
| Proprietary Name | Robinul |
| Package Description | 1 VIAL in 1 BAG (52584-107-01) > 20 mL in 1 VIAL |
| Product NDC | 52584-107 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Robinul |
| Dosage Form Name | INJECTION |
| Route Name | INTRAMUSCULAR; INTRAVENOUS |
| Start Marketing Date | 20121011 |
| Marketing Category Name | NDA |
| Labeler Name | General Injectables & Vaccines, Inc |
| Substance Name | GLYCOPYRROLATE |
| Strength Number | .2 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Anticholinergic [EPC],Cholinergic Antagonists [MoA] |