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Serving leading biopharmaceutical companies globally:

Medtronic
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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076390

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NDA 076390 describes TERBINAFINE HYDROCHLORIDE, which is a drug marketed by Taro, Apotex, Aurobindo Pharma, Breckenridge Pharm, Cipla Ltd, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, Invagen Pharms, Mylan, Orchid Hlthcare, Roxane, Teva, and Wockhardt, 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-six 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 076390

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 076390

Ingredient-typeAllylamine

Suppliers and Packaging for NDA: 076390

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 076390 ANDA Dr.Reddys Laboratories Limited 55111-250 55111-250-05 500 TABLET in 1 BOTTLE (55111-250-05)
TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 076390 ANDA Dr.Reddys Laboratories Limited 55111-250 55111-250-79 10 BLISTER PACK in 1 CARTON (55111-250-79) > 10 TABLET in 1 BLISTER PACK (55111-250-78)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Queensland Health
Healthtrust
McKinsey
Teva
Fuji
Chinese Patent Office
Cerilliant
Dow
Mallinckrodt
Daiichi Sankyo

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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