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Generated: January 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076133

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NDA 076133 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 Pharms Inc, 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 Usa Inc, 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 076133
Applicant:Dr Reddys Labs Ltd
Formulation / Manufacturing:see details
Pharmacology for NDA: 076133
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 Teva Pharmaceuticals USA Inc 0093-5105 0093-5105-01 100 TABLET, FILM COATED in 1 BOTTLE (0093-5105-01)
OLANZAPINE olanzapine TABLET;ORAL 076133 ANDA Teva Pharmaceuticals USA Inc 0093-5105 0093-5105-05 500 TABLET, FILM COATED in 1 BOTTLE (0093-5105-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Apr 23, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Oct 24, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Argus Health
Boehringer Ingelheim

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