NDC 0002-3234
Symbyax
Olanzapine And Fluoxetine Hydrochloride
Symbyax is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Eli Lilly And Company. The primary component is Olanzapine; Fluoxetine Hydrochloride.
| Product ID | 0002-3234_087c16dc-e0c2-4c5b-8cc8-f703a992f5d9 |
| NDC | 0002-3234 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Symbyax |
| Generic Name | Olanzapine And Fluoxetine Hydrochloride |
| Dosage Form | Capsule |
| Route of Administration | ORAL |
| Marketing Start Date | 2003-12-24 |
| Marketing End Date | 2021-04-26 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021520 |
| Labeler Name | Eli Lilly and Company |
| Substance Name | OLANZAPINE; FLUOXETINE HYDROCHLORIDE |
| Active Ingredient Strength | 12 mg/1; mg/1 |
| Pharm Classes | Atypical Antipsychotic [EPC],Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |
| NDC Exclude Flag | N |
Packaging
NDC 0002-3234-30
30 CAPSULE in 1 BOTTLE (0002-3234-30)
| Marketing Start Date | 2004-01-19 |
| Marketing End Date | 2021-04-26 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0002-3234-02 [00002323402]
Symbyax CAPSULE
| Marketing Category | NDA |
| Application Number | NDA021520 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-12-24 |
| Marketing End Date | 2010-10-22 |
NDC 0002-3234-04 [00002323404]
Symbyax CAPSULE
| Marketing Category | NDA |
| Application Number | NDA021520 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2003-12-24 |
| Marketing End Date | 2010-10-22 |
NDC 0002-3234-30 [00002323430]
Symbyax CAPSULE
| Marketing Category | NDA |
| Application Number | NDA021520 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2004-01-19 |
| Marketing End Date | 2021-04-26 |
NDC 0002-3234-01 [00002323401]
Symbyax CAPSULE
| Marketing Category | NDA |
| Application Number | NDA021520 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2003-12-24 |
| Marketing End Date | 2013-01-19 |
NDC 0002-3234-33 [00002323433]
Symbyax CAPSULE
| Marketing Category | NDA |
| Application Number | NDA021520 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2003-12-24 |
| Marketing End Date | 2013-01-19 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| OLANZAPINE | 12 mg/1 |
OpenFDA Data
| SPL SET ID: | 6b28c424-0b7e-4b75-b090-f116b113554e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
Pharmacological Class
- Atypical Antipsychotic [EPC]
- Serotonin Reuptake Inhibitor [EPC]
- Serotonin Uptake Inhibitors [MoA]
NDC Crossover Matching brand name "Symbyax" or generic name "Olanzapine And Fluoxetine Hydrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0002-3230 | Symbyax | Olanzapine and Fluoxetine hydrochloride |
| 0002-3231 | Symbyax | Olanzapine and Fluoxetine hydrochloride |
| 0002-3232 | Symbyax | Olanzapine and Fluoxetine hydrochloride |
| 0002-3233 | Symbyax | Olanzapine and Fluoxetine hydrochloride |
| 0002-3234 | Symbyax | Olanzapine and Fluoxetine hydrochloride |
Trademark Results [Symbyax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYMBYAX 76230425 2926531 Live/Registered |
Eli Lilly and Company 2001-03-26 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.