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Last Updated: January 23, 2021

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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 one supplier. Additional details are available on the AMNESTEEM profile page.

The generic ingredient in AMNESTEEM 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 075945
Tradename:AMNESTEEM
Applicant:Mylan Pharms Inc
Ingredient:isotretinoin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075945
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)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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