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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076485

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NDA 076485 describes MYORISAN, which is a drug marketed by Douglas Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the MYORISAN profile page.

The generic ingredient in MYORISAN is isotretinoin. There are thirteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.
Summary for 076485
Tradename:MYORISAN
Applicant:Douglas Pharms
Ingredient:isotretinoin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076485
Ingredient-typeRetinoids
Medical Subject Heading (MeSH) Categories for 076485
Suppliers and Packaging for NDA: 076485
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYORISAN isotretinoin CAPSULE;ORAL 076485 ANDA VersaPharm, Inc. ? An Akorn Company 61748-301 61748-301-01 5000 CAPSULE, LIQUID FILLED in 1 BAG (61748-301-01)
MYORISAN isotretinoin CAPSULE;ORAL 076485 ANDA VersaPharm, Inc. ? An Akorn Company 61748-301 61748-301-11 10 BLISTER PACK in 1 CARTON (61748-301-11) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jan 19, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Jan 19, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Jan 19, 2012TE:ABRLD:No

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