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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Healthtrust
UBS
Federal Trade Commission
Cipla
Daiichi Sankyo
AstraZeneca
Cantor Fitzgerald
QuintilesIMS
Colorcon

Generated: July 21, 2017

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Details for New Drug Application (NDA): 074512

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NDA 074512 describes CLEMASTINE FUMARATE, which is a drug marketed by Apotex Inc, L Perrigo Co, Sandoz, Wockhardt, Actavis Mid Atlantic, Ani Pharms Inc, Teva, Silarx, and Teva Pharms, and is included in eleven NDAs. It is available from sixteen suppliers. Additional details are available on the CLEMASTINE FUMARATE profile page.

The generic ingredient in CLEMASTINE FUMARATE is clemastine fumarate. There are two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.

Summary for NDA: 074512

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 074512

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLEMASTINE FUMARATE
clemastine fumarate
TABLET;ORAL 074512 ANDA L Perrigo Company 0113-0282 0113-0282-73 2 BLISTER PACK in 1 CARTON (0113-0282-73) > 8 TABLET in 1 BLISTER PACK
CLEMASTINE FUMARATE
clemastine fumarate
TABLET;ORAL 074512 ANDA Walgreen Company 0363-0282 0363-0282-73 2 BLISTER PACK in 1 CARTON (0363-0282-73) > 8 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength1.34MG
Approval Date:Nov 22, 1995TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Baxter
Covington
US Department of Justice
Cipla
Boehringer Ingelheim
Chubb
Mallinckrodt
Accenture
Express Scripts
Johnson and Johnson

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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