Details for New Drug Application (NDA): 202295
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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 202295
Tradename: | OLANZAPINE |
Applicant: | Alkem Labs Ltd |
Ingredient: | olanzapine |
Patents: | 0 |
Suppliers and Packaging for NDA: 202295
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLANZAPINE | olanzapine | TABLET;ORAL | 202295 | ANDA | Ascend Laboratories, LLC | 67877-172 | 67877-172-01 | 100 TABLET in 1 BOTTLE (67877-172-01) |
OLANZAPINE | olanzapine | TABLET;ORAL | 202295 | ANDA | Ascend Laboratories, LLC | 67877-172 | 67877-172-10 | 1000 TABLET in 1 BOTTLE (67877-172-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Oct 20, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Oct 20, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
Approval Date: | Oct 20, 2015 | TE: | AB | RLD: | No |
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