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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Mallinckrodt
McKinsey
Harvard Business School
Merck
Citi
McKesson
Julphar
Queensland Health

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075945

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NDA 075945 describes AMNESTEEM, which is a drug marketed by Mylan Pharms Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the AMNESTEEM profile page.

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

Summary for 075945

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

Pharmacology for NDA: 075945

Ingredient-typeRetinoids

Medical Subject Heading (MeSH) Categories for 075945

Suppliers and Packaging for NDA: 075945

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMNESTEEM isotretinoin CAPSULE;ORAL 075945 ANDA Mylan Pharmaceuticals Inc. 0378-6611 0378-6611-93 3 BLISTER PACK in 1 CARTON (0378-6611-93) > 10 CAPSULE in 1 BLISTER PACK (0378-6611-85)
AMNESTEEM isotretinoin CAPSULE;ORAL 075945 ANDA Mylan Pharmaceuticals Inc. 0378-6612 0378-6612-93 3 BLISTER PACK in 1 CARTON (0378-6612-93) > 10 CAPSULE in 1 BLISTER PACK (0378-6612-85)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Nov 8, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Nov 8, 2002TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Nov 8, 2002TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Medtronic
Covington
McKesson
Merck
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Argus Health
Novartis
Queensland Health

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