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Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074884

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NDA 074884 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 fifteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the clemastine fumarate profile page.

Summary for 074884

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 074884

Suppliers and Packaging for NDA: 074884

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLEMASTINE FUMARATE
clemastine fumarate
SYRUP;ORAL 074884 ANDA Silarx Pharmaceuticals, Inc 54838-514 54838-514-40 120 mL in 1 BOTTLE, PLASTIC (54838-514-40)
CLEMASTINE FUMARATE
clemastine fumarate
SYRUP;ORAL 074884 ANDA Silarx Pharmaceuticals, Inc 54838-514 54838-514-80 473 mL in 1 BOTTLE, PLASTIC (54838-514-80)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrengthEQ 0.5MG BASE/5ML
Approval Date:Dec 17, 1997TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
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Baxter
Express Scripts
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US Department of Justice
Boehringer Ingelheim
Mallinckrodt

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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