| Product NDC: | 43386-480 |
| Proprietary Name: | Orphenadrine Citrate |
| Non Proprietary Name: | Orphenadrine Citrate |
| Active Ingredient(s): | 100 mg/1 & nbsp; Orphenadrine Citrate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 43386-480 |
| Labeler Name: | Gavis Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA040284 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 19980619 |
| Package NDC: | 43386-480-26 |
| Package Description: | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-26) |
| NDC Code | 43386-480-26 |
| Proprietary Name | Orphenadrine Citrate |
| Package Description | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (43386-480-26) |
| Product NDC | 43386-480 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Orphenadrine Citrate |
| Dosage Form Name | TABLET, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 19980619 |
| Marketing Category Name | ANDA |
| Labeler Name | Gavis Pharmaceuticals, LLC |
| Substance Name | ORPHENADRINE CITRATE |
| Strength Number | 100 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] |