Product NDC: | 16590-596 |
Proprietary Name: | Amrix |
Non Proprietary Name: | Cyclobenzaprine Hydrochloride |
Active Ingredient(s): | 15 mg/1 & nbsp; Cyclobenzaprine Hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | CAPSULE, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 16590-596 |
Labeler Name: | STAT RX USA LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021777 |
Marketing Category: | NDA |
Start Marketing Date: | 20071001 |
Package NDC: | 16590-596-28 |
Package Description: | 28 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16590-596-28) |
NDC Code | 16590-596-28 |
Proprietary Name | Amrix |
Package Description | 28 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16590-596-28) |
Product NDC | 16590-596 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Cyclobenzaprine Hydrochloride |
Dosage Form Name | CAPSULE, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20071001 |
Marketing Category Name | NDA |
Labeler Name | STAT RX USA LLC |
Substance Name | CYCLOBENZAPRINE HYDROCHLORIDE |
Strength Number | 15 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC] |