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Cantor Fitzgerald
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US Department of Justice
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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077684

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NDA 077684 describes TRETINOIN, which is a drug marketed by Anchen Pharms, Barr Labs Inc, Glenmark Pharms Ltd, Allergan Sales Llc, Perrigo Pharma Intl, Zo Skin Health, Mylan Pharms Inc, Teva Pharms, and Wockhardt, and is included in sixteen NDAs. It is available from fourteen suppliers. Additional details are available on the TRETINOIN profile page.

The generic ingredient in TRETINOIN is tretinoin. There are twenty-four drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the tretinoin profile page.
Summary for 077684
Tradename:TRETINOIN
Applicant:Barr Labs Inc
Ingredient:tretinoin
Patents:0
Therapeutic Class:Antineoplastics
Dermatological Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077684
Ingredient-typeRetinoids
Medical Subject Heading (MeSH) Categories for 077684
Suppliers and Packaging for NDA: 077684
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRETINOIN tretinoin CAPSULE;ORAL 077684 ANDA Barr Laboratories Inc. 0555-0808 N 0555-0808-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jun 22, 2007TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Harvard Business School
Merck
Queensland Health
Mallinckrodt
McKesson
QuintilesIMS
Covington

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