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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076356

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NDA 076356 describes CLARAVIS, which is a drug marketed by Teva Pharms Usa and is included in two NDAs. It is available from one supplier. Additional details are available on the CLARAVIS profile page.

The generic ingredient in CLARAVIS 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 076356
Tradename:CLARAVIS
Applicant:Teva Pharms Usa
Ingredient:isotretinoin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076356
Ingredient-typeRetinoids
Medical Subject Heading (MeSH) Categories for 076356
Suppliers and Packaging for NDA: 076356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARAVIS isotretinoin CAPSULE;ORAL 076356 ANDA Teva Pharmaceuticals USA, Inc. 0555-1054 0555-1054-56 10 BLISTER PACK in 1 CARTON (0555-1054-56) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1054-60)
CLARAVIS isotretinoin CAPSULE;ORAL 076356 ANDA Teva Pharmaceuticals USA, Inc. 0555-1054 0555-1054-86 3 BLISTER PACK in 1 CARTON (0555-1054-86) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1054-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Apr 11, 2003TE:ABRLD:No

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