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Serving 500+ biopharmaceutical companies globally:

US Army
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Generated: July 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091455

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NDA 091455 describes ACITRETIN, which is a drug marketed by Mylan Pharms Inc, Sigmapharm Labs Llc, Impax Labs Inc, Barr Labs Inc, and Teva Pharms Usa, and is included in six NDAs. It is available from five 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. Seven suppliers are listed for this compound. Additional details are available on the acitretin profile page.

Summary for NDA: 091455

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

Pharmacology for NDA: 091455

Ingredient-typeRetinoids

Suppliers and Packaging for NDA: 091455

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACITRETIN
acitretin
CAPSULE;ORAL 091455 ANDA Teva Pharmaceuticals USA, Inc. 0093-1135 0093-1135-56 30 CAPSULE in 1 BOTTLE (0093-1135-56)
ACITRETIN
acitretin
CAPSULE;ORAL 091455 ANDA Teva Pharmaceuticals USA, Inc. 0093-1136 0093-1136-56 30 CAPSULE in 1 BOTTLE (0093-1136-56)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Apr 4, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Apr 4, 2013TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Merck
Medtronic
US Army
Moodys
Covington
Colorcon
Chubb
Cantor Fitzgerald
Deloitte
Harvard Business School

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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