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Generated: January 16, 2019

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Details for New Drug Application (NDA): 076135

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NDA 076135 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 076135
Tradename:CLARAVIS
Applicant:Teva Pharms Usa
Ingredient:isotretinoin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076135
Medical Subject Heading (MeSH) Categories for 076135
Suppliers and Packaging for NDA: 076135
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CLARAVIS isotretinoin CAPSULE;ORAL 076135 ANDA Teva Pharmaceuticals USA, Inc. 0555-1055 0555-1055-56 10 BLISTER PACK in 1 CARTON (0555-1055-56) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60)
CLARAVIS isotretinoin CAPSULE;ORAL 076135 ANDA Teva Pharmaceuticals USA, Inc. 0555-1055 0555-1055-86 3 BLISTER PACK in 1 CARTON (0555-1055-86) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0555-1055-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:Apr 11, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Apr 11, 2003TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:May 11, 2006TE:ABRLD:No

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