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Details for New Drug Application (NDA): 201588

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NDA 201588 describes OLANZAPINE, which is a drug marketed by Teva Pharms, Ivax Pharms Inc, Aurobindo Pharma Ltd, Par Pharm, Ajanta Pharma Ltd, Torrent Pharms Llc, Qilu Pharm Co Ltd, Jubilant Generics, Dr Reddys Labs Ltd, Invagen Pharms, Torrent Pharms Ltd, Orchid Hlthcare, Sun Pharm Inds, Luitpold, Barr Labs Inc, Macleods Pharms Ltd, Apotex Inc, Mylan, Mylan Pharms Inc, Sandoz Inc, Alkem Labs Ltd, and Sandoz, and is included in thirty-three NDAs. It is available from forty 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 NDA: 201588

Tradename:
OLANZAPINE
Applicant:
Sandoz Inc
Ingredient:
olanzapine
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 201588

Suppliers and Packaging for NDA: 201588

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLANZAPINE
olanzapine
INJECTABLE;INTRAMUSCULAR 201588 ANDA Sandoz Inc 0781-3159 0781-3159-72 1 VIAL in 1 CARTON (0781-3159-72) > 2 mL in 1 VIAL
OLANZAPINE
olanzapine
INJECTABLE;INTRAMUSCULAR 201588 ANDA Sandoz Inc 0781-9105 0781-9105-72 1 VIAL in 1 CARTON (0781-9105-72) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULARStrength10MG/VIAL
Approval Date:Oct 24, 2011TE:APRLD:No


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