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Quetiapine Fumarate
Quetiapine Fumarate - 0054-0221-25 - (Quetiapine Fumarate)
Drug Information of Quetiapine Fumarate
| Product NDC: | 0054-0221 |
| Proprietary Name: | Quetiapine Fumarate |
| Non Proprietary Name: | Quetiapine Fumarate |
| Active Ingredient(s): | 100 mg/1 & nbsp; Quetiapine Fumarate |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of Quetiapine Fumarate
| Product NDC: | 0054-0221 |
| Labeler Name: | Roxane Laboratories, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA090120 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120327 |
Package Information of Quetiapine Fumarate
| Package NDC: | 0054-0221-25 |
| Package Description: | 100 TABLET in 1 BOTTLE (0054-0221-25) |
NDC Information of Quetiapine Fumarate
| NDC Code | 0054-0221-25 |
| Proprietary Name | Quetiapine Fumarate |
| Package Description | 100 TABLET in 1 BOTTLE (0054-0221-25) |
| Product NDC | 0054-0221 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Quetiapine Fumarate |
| Dosage Form Name | TABLET |
| Route Name | ORAL |
| Start Marketing Date | 20120327 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc. |
| Substance Name | QUETIAPINE FUMARATE |
| Strength Number | 100 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Atypical Antipsychotic [EPC] |
