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Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078229

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NDA 078229 describes TERBINAFINE HYDROCHLORIDE, which is a drug marketed by Taro, Breckenridge Pharm, Harris Pharm, Roxane, Wockhardt, Invagen Pharms, Mylan, Cipla Ltd, Glenmark Generics, Orchid Hlthcare, Gedeon Richter Usa, Teva, Dr Reddys Labs Inc, Aurobindo Pharma, and Apotex, and is included in sixteen NDAs. It is available from fifty-one suppliers. Additional details are available on the TERBINAFINE HYDROCHLORIDE profile page.

The generic ingredient in TERBINAFINE HYDROCHLORIDE is terbinafine hydrochloride. There are twenty-five drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the terbinafine hydrochloride profile page.

Summary for NDA: 078229

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 078229

Ingredient-typeAllylamine

Suppliers and Packaging for NDA: 078229

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL 078229 ANDA Wockhardt Limited 55648-743 55648-743-01 30 TABLET in 1 BOTTLE (55648-743-01)
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride
TABLET;ORAL 078229 ANDA Wockhardt Limited 55648-743 55648-743-02 1000 TABLET in 1 BOTTLE (55648-743-02)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Jul 2, 2007TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Deloitte
McKinsey
QuintilesIMS
Cantor Fitzgerald
Farmers Insurance
Boehringer Ingelheim
Queensland Health
Julphar
Citi

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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