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Details for New Drug Application (NDA): 091331

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NDA 091331 describes ANASTROZOLE, which is a drug marketed by Sandoz, Natco Pharma Ltd, Zydus Pharms Usa Inc, Synthon Pharms, Kremers Urban Pharms, Dr Reddys Labs Ltd, Impax Labs Inc, Santos Biotech, Mylan, Apotex Inc, Teva Pharms, Cipla Ltd, Accord Hlthcare, Sun Pharm Inds Ltd, Watson Labs, Roxane, and Fresenius Kabi Oncol, and is included in seventeen NDAs. It is available from thirty-three suppliers. Additional details are available on the ANASTROZOLE profile page.

The generic ingredient in ANASTROZOLE is anastrozole. There are twenty-four drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the anastrozole profile page.

Summary for NDA: 091331

Tradename:
ANASTROZOLE
Applicant:
Kremers Urban Pharms
Ingredient:
anastrozole
Patents:0
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details

Pharmacology for NDA: 091331

Mechanism of ActionAromatase Inhibitors

Suppliers and Packaging for NDA: 091331

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANASTROZOLE
anastrozole
TABLET;ORAL 091331 ANDA Kremers Urban Pharmaceuticals Inc. 62175-710 62175-710-32 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62175-710-32)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength1MG
Approval Date:Jan 5, 2011TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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