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Details for New Drug Application (NDA): 076387

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NDA 076387 describes CLOTRIMAZOLE, which is a drug marketed by Teva, Glenmark Pharms, Fougera Pharms, Taro, Paddock Llc, Actavis Mid Atlantic, and Roxane, and is included in fifteen NDAs. It is available from twenty-one suppliers. Additional details are available on the CLOTRIMAZOLE profile page.

The generic ingredient in CLOTRIMAZOLE is betamethasone dipropionate; clotrimazole. There are sixty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate; clotrimazole profile page.

Summary for NDA: 076387

Tradename:
CLOTRIMAZOLE
Applicant:
Roxane
Ingredient:
clotrimazole
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 076387

Ingredient-typeAzoles

Suppliers and Packaging for NDA: 076387

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLOTRIMAZOLE
clotrimazole
TROCHE/LOZENGE;ORAL 076387 ANDA West-Ward Pharmaceuticals Corp. 0054-4146 0054-4146-22 70 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-22)
CLOTRIMAZOLE
clotrimazole
TROCHE/LOZENGE;ORAL 076387 ANDA West-Ward Pharmaceuticals Corp. 0054-4146 0054-4146-23 140 LOZENGE in 1 BOTTLE, PLASTIC (0054-4146-23)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TROCHE/LOZENGE;ORALStrength10MG
Approval Date:Jul 29, 2004TE:ABRLD:Yes


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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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