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Details for New Drug Application (NDA): 205573

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NDA 205573 describes ITRACONAZOLE, which is a drug marketed by Sandoz, Par Pharm Inc, Alembic Pharms Ltd, Mylan Pharms Inc, Amneal Pharms, and Accord Hlthcare, and is included in seven NDAs. It is available from seven suppliers. Additional details are available on the ITRACONAZOLE profile page.

The generic ingredient in ITRACONAZOLE is itraconazole. There are fifteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the itraconazole profile page.

Summary for NDA: 205573

Tradename:
ITRACONAZOLE
Applicant:
Amneal Pharms
Ingredient:
itraconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 205573

Suppliers and Packaging for NDA: 205573

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ITRACONAZOLE
itraconazole
SOLUTION;ORAL 205573 ANDA Amneal Pharmaceuticals LLC 65162-087 65162-087-74 150 mL in 1 BOTTLE, GLASS (65162-087-74)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:Oct 30, 2015TE: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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