Details for New Drug Application (NDA): 076133
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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 076133
Tradename: | OLANZAPINE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | olanzapine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076133
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLANZAPINE | olanzapine | TABLET;ORAL | 076133 | ANDA | Major Pharmaceuticals | 0904-6286 | 0904-6286-06 | 50 BLISTER PACK in 1 CARTON (0904-6286-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
OLANZAPINE | olanzapine | TABLET;ORAL | 076133 | ANDA | Major Pharmaceuticals | 0904-6286 | 0904-6286-61 | 100 BLISTER PACK in 1 CARTON (0904-6286-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
Approval Date: | Apr 23, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Oct 24, 2011 | TE: | AB | RLD: | No |
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