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Serving 500+ biopharmaceutical companies globally:

Covington
US Army
AstraZeneca
Harvard Business School
Boehringer Ingelheim
Fuji
Daiichi Sankyo
Citi
US Department of Justice
Queensland Health

Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 008372

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NDA 008372 describes H.P. ACTHAR GEL, which is a drug marketed by Mallinckrodt Ard and is included in one NDA. Additional details are available on the H.P. ACTHAR GEL profile page.

The generic ingredient in H.P. ACTHAR GEL is corticotropin. There are ten drug master file entries for this compound. Additional details are available on the corticotropin profile page.

Summary for NDA: 008372

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

Summary for product number 006

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength40 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 008

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80 UNITS/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 15, 2017
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY


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Serving 500+ biopharmaceutical companies globally:

Medtronic
Deloitte
Healthtrust
Baxter
Harvard Business School
Queensland Health
Covington
US Army
AstraZeneca
Dow

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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