| Product NDC: | 0517-0955 |
| Proprietary Name: | Olanzapine |
| Non Proprietary Name: | Olanzapine |
| Active Ingredient(s): | 10 mg/2mL & nbsp; Olanzapine |
| Administration Route(s): | INTRAMUSCULAR |
| Dosage Form(s): | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0517-0955 |
| Labeler Name: | American Regent, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA201741 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20120627 |
| Package NDC: | 0517-0955-01 |
| Package Description: | 1 VIAL, GLASS in 1 CARTON (0517-0955-01) > 2 mL in 1 VIAL, GLASS |
| NDC Code | 0517-0955-01 |
| Proprietary Name | Olanzapine |
| Package Description | 1 VIAL, GLASS in 1 CARTON (0517-0955-01) > 2 mL in 1 VIAL, GLASS |
| Product NDC | 0517-0955 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Olanzapine |
| Dosage Form Name | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
| Route Name | INTRAMUSCULAR |
| Start Marketing Date | 20120627 |
| Marketing Category Name | ANDA |
| Labeler Name | American Regent, Inc. |
| Substance Name | OLANZAPINE |
| Strength Number | 10 |
| Strength Unit | mg/2mL |
| Pharmaceutical Classes | Atypical Antipsychotic [EPC] |