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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Deloitte
Federal Trade Commission
AstraZeneca
Chubb
Cantor Fitzgerald
Healthtrust
Mallinckrodt
Colorcon
Daiichi Sankyo
Citi

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204633

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NDA 204633 describes ACITRETIN, which is a drug marketed by Barr Labs Inc, Impax Labs Inc, Mylan Pharms Inc, Sigmapharm Labs Llc, and Teva Pharms Usa, and is included in six NDAs. It is available from six suppliers. Additional details are available on the ACITRETIN profile page.

The generic ingredient in ACITRETIN is acitretin. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acitretin profile page.

Summary for 204633

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

Pharmacology for NDA: 204633

Ingredient-typeRetinoids

Medical Subject Heading (MeSH) Categories for 204633

Suppliers and Packaging for NDA: 204633

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACITRETIN acitretin CAPSULE;ORAL 204633 ANDA AvKARE, Inc. 42291-086 42291-086-30 30 CAPSULE in 1 BOTTLE (42291-086-30)
ACITRETIN acitretin CAPSULE;ORAL 204633 ANDA AvKARE, Inc. 42291-087 42291-087-30 30 CAPSULE in 1 BOTTLE (42291-087-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:May 22, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength17.5MG
Approval Date:May 22, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength22.5MG
Approval Date:May 22, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Covington
Citi
Merck
McKinsey
Harvard Business School
Teva
Dow
Cantor Fitzgerald
Moodys
UBS

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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