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Generated: June 26, 2019

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Details for New Drug Application (NDA): 076255

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NDA 076255 describes OLANZAPINE, which is a drug marketed by Luitpold, Sandoz Inc, Ajanta Pharma Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Dr Reddys Labs Ltd, Hec Pharm, Invagen Pharms, Jubilant Generics, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Par Pharm, Sun Pharm Inds, Torrent Pharms Llc, Alkem Labs Ltd, Hikma Pharms, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Qilu Pharm Co Ltd, Sunshine Lake, Teva Pharms, Torrent Pharms Ltd, Zydus Pharms, and Sandoz, and is included in thirty-nine NDAs. It is available from forty-three suppliers. Additional details are available on the OLANZAPINE profile page.

The generic ingredient in OLANZAPINE is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
Summary for 076255
Tradename:OLANZAPINE
Applicant:Dr Reddys Labs Ltd
Ingredient:olanzapine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076255
Suppliers and Packaging for NDA: 076255
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLANZAPINE olanzapine TABLET;ORAL 076255 ANDA Major Pharmaceuticals 0904-6283 0904-6283-61 100 BLISTER PACK in 1 CARTON (0904-6283-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK
OLANZAPINE olanzapine TABLET;ORAL 076255 ANDA Major Pharmaceuticals 0904-6376 0904-6376-61 100 BLISTER PACK in 1 CARTON (0904-6376-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Apr 23, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 23, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Apr 23, 2012TE:ABRLD:No

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