Details for New Drug Application (NDA): 202862
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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 202862
Tradename: | OLANZAPINE |
Applicant: | Macleods Pharms Ltd |
Ingredient: | olanzapine |
Patents: | 0 |
Suppliers and Packaging for NDA: 202862
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLANZAPINE | olanzapine | TABLET;ORAL | 202862 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8243 | 0615-8243-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8243-39) |
OLANZAPINE | olanzapine | TABLET;ORAL | 202862 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8244 | 0615-8244-05 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8244-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
Approval Date: | Aug 15, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Aug 15, 2014 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7.5MG | ||||
Approval Date: | Aug 15, 2014 | TE: | AB | RLD: | No |
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