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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
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Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202317

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NDA 202317 describes VALCHLOR, which is a drug marketed by Actelion Pharms Ltd and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the VALCHLOR profile page.

The generic ingredient in VALCHLOR is mechlorethamine hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the mechlorethamine hydrochloride profile page.

Summary for 202317

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:6
Formulation / Manufacturing:see details

Pharmacology for NDA: 202317

Mechanism of ActionAlkylating Activity

Medical Subject Heading (MeSH) Categories for 202317

Suppliers and Packaging for NDA: 202317

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALCHLOR
mechlorethamine hydrochloride
GEL;TOPICAL 202317 NDA Actelion Pharmaceuticals US, Inc. 66215-001 66215-001-05 1 TUBE in 1 CARTON (66215-001-05) > 5 g in 1 TUBE
VALCHLOR
mechlorethamine hydrochloride
GEL;TOPICAL 202317 NDA Actelion Pharmaceuticals US, Inc. 66215-016 66215-016-60 1 TUBE in 1 CARTON (66215-016-60) > 60 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrengthEQ 0.016% BASE
Approval Date:Aug 23, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 23, 2016
Regulatory Exclusivity Use:NEW DOSAGE FORM
Regulatory Exclusivity Expiration:Aug 23, 2020
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:► SubscribePatent Expiration:Mar 7, 2026Product Flag?YSubstance Flag?Delist Request?


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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
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Harvard Business School
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Fish and Richardson
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QuintilesIMS
Farmers Insurance

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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