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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 076255


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NDA 076255 describes OLANZAPINE, which is a drug marketed by Am Regent, Aspiro, Eugia Pharma, Sandoz Inc, Ajanta Pharma Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Chartwell Molecular, Dr Reddys Labs Ltd, Hec Pharm, Hisun Pharm Hangzhou, Jubilant Generics, Macleods Pharms Ltd, Mylan, Orbion Pharms, Strides Pharma, Sun Pharm Inds, Torrent, Zydus Pharms, Alkem Labs Ltd, Cadila Pharms Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Qilu, Sunshine, Teva Pharms, Torrent Pharms Ltd, Epic Pharma Llc, and Par Pharm, and is included in forty-six 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. Four 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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