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Details for New Drug Application (NDA): 090862

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NDA 090862 describes VORICONAZOLE, which is a drug marketed by Glenmark Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Mylan Pharms Inc, Zydus Pharms Usa Inc, Versapharm Inc, Prinston Inc, Teva Pharms, Sandoz Inc, Appco Pharma Llc, Novel Labs Inc, Ajanta Pharma Ltd, and Alvogen Inc, and is included in sixteen NDAs. It is available from twenty-one suppliers. Additional details are available on the VORICONAZOLE profile page.

The generic ingredient in VORICONAZOLE is voriconazole. There are eleven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the voriconazole profile page.

Summary for NDA: 090862

Sandoz Inc
Therapeutic Class:Antifungals

Suppliers and Packaging for NDA: 090862

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;IV (INFUSION) 090862 ANDA Sandoz Inc 0781-3416 0781-3416-94 1 VIAL, SINGLE-USE in 1 CARTON (0781-3416-94) > 20 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength200MG/VIAL
Approval Date:May 30, 2012TE:APRLD: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.