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Details for New Drug Application (NDA): 075597

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NDA 075597 describes KETOCONAZOLE, which is a drug marketed by Apotex, Sun Pharm Inds, Perrigo New York, Taro, Aaipharma Llc, Tolmar, Perrigo Israel, Pliva, Teva, Fougera Pharms, and Mylan, and is included in thirteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the KETOCONAZOLE profile page.

The generic ingredient in KETOCONAZOLE is ketoconazole. There are fifteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the ketoconazole profile page.

Summary for NDA: 075597

Tradename:
KETOCONAZOLE
Applicant:
Mylan
Ingredient:
ketoconazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 075597

Suppliers and Packaging for NDA: 075597

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOCONAZOLE
ketoconazole
TABLET;ORAL 075597 ANDA KAISER FOUNDATION HOSPITALS 0179-0055 0179-0055-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0055-70)
KETOCONAZOLE
ketoconazole
TABLET;ORAL 075597 ANDA Mylan Pharmaceuticals Inc. 0378-0261 0378-0261-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0261-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Dec 23, 1999TE:ABRLD: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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