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Generated: June 16, 2019

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Details for New Drug Application (NDA): 078109

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NDA 078109 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 078109
Tradename:OLANZAPINE
Applicant:Par Pharm
Ingredient:olanzapine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078109
Suppliers and Packaging for NDA: 078109
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 078109 ANDA Par Pharmaceutical, Inc. 49884-320 49884-320-55 3 BLISTER PACK in 1 CARTON (49884-320-55) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-320-52)
OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 078109 ANDA Par Pharmaceutical, Inc. 49884-321 49884-321-55 3 BLISTER PACK in 1 CARTON (49884-321-55) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-321-52)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:Oct 24, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Oct 24, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Oct 24, 2011TE:ABRLD:No

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