Details for New Drug Application (NDA): 076534
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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 076534
Tradename: | OLANZAPINE |
Applicant: | Dr Reddys Labs Ltd |
Ingredient: | olanzapine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 076534
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OLANZAPINE | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 076534 | ANDA | Dr.Reddy's Laboratories Limited | 55111-262 | 55111-262-79 | 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (55111-262-79) |
OLANZAPINE | olanzapine | TABLET, ORALLY DISINTEGRATING;ORAL | 076534 | ANDA | Dr.Reddy's Laboratories Limited | 55111-262 | 55111-262-81 | 3 BLISTER PACK in 1 CARTON (55111-262-81) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 5MG | ||||
Approval Date: | Oct 24, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 24, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 15MG | ||||
Approval Date: | Oct 24, 2011 | TE: | AB | RLD: | No |
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