Details for New Drug Application (NDA): 204319
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The generic ingredient in OLANZAPINE is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
Summary for 204319
Tradename: | OLANZAPINE |
Applicant: | Qilu |
Ingredient: | olanzapine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 204319
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLANZAPINE | olanzapine | TABLET;ORAL | 204319 | ANDA | RPK Pharmaceuticals, Inc. | 53002-2505 | 53002-2505-3 | 30 TABLET in 1 BOTTLE (53002-2505-3) |
OLANZAPINE | olanzapine | TABLET;ORAL | 204319 | ANDA | Virtus Pharmaceuticals, LLC | 69543-380 | 69543-380-30 | 30 TABLET in 1 BOTTLE (69543-380-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Jan 27, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jan 27, 2016 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
Approval Date: | Jan 27, 2016 | TE: | AB | RLD: | No |
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