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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 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. Six suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.

Summary for NDA: 075945

Tradename:
AMNESTEEM
Applicant:
Mylan Pharms Inc
Ingredient:
isotretinoin
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075945

Ingredient-typeRetinoids

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. 0378-6612 0378-6612-93 3 BLISTER PACK in 1 CARTON (0378-6612-93) > 10 CAPSULE in 1 BLISTER PACK (0378-6612-85)
AMNESTEEM
isotretinoin
CAPSULE;ORAL 075945 ANDA Mylan Pharmaceuticals Inc. 0378-6614 0378-6614-93 3 BLISTER PACK in 1 CARTON (0378-6614-93) > 10 CAPSULE in 1 BLISTER PACK (0378-6614-85)

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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