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Rozerem
Rozerem - 35356-092-30 - (Rozerem)
Drug Information of Rozerem
| Product NDC: | 35356-092 |
| Proprietary Name: | Rozerem |
| Non Proprietary Name: | Rozerem |
| Active Ingredient(s): | 8 mg/1 & nbsp; Rozerem |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Rozerem
| Product NDC: | 35356-092 |
| Labeler Name: | Lake Erie Medical DBA Quality Care Products LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021782 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110518 |
Package Information of Rozerem
| Package NDC: | 35356-092-30 |
| Package Description: | 30 TABLET, FILM COATED in 1 BOTTLE (35356-092-30) |
NDC Information of Rozerem
| NDC Code | 35356-092-30 |
| Proprietary Name | Rozerem |
| Package Description | 30 TABLET, FILM COATED in 1 BOTTLE (35356-092-30) |
| Product NDC | 35356-092 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Rozerem |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20110518 |
| Marketing Category Name | NDA |
| Labeler Name | Lake Erie Medical DBA Quality Care Products LLC |
| Substance Name | RAMELTEON |
| Strength Number | 8 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Melatonin Receptor Agonist [EPC],Melatonin Receptor Agonists [MoA] |
