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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
AstraZeneca
QuintilesIMS
Novartis
Healthtrust
Dow
Fuji
Merck
Johnson and Johnson
Accenture

Generated: October 18, 2017

DrugPatentWatch Database Preview

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 two suppliers. Additional details are available on the CLARAVIS profile page.

The generic ingredient in CLARAVIS is isotretinoin. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the isotretinoin profile page.

Summary for NDA: 076135

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076135

Ingredient-typeRetinoids

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)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving leading biopharmaceutical companies globally:

Citi
McKinsey
Baxter
Colorcon
Novartis
Merck
McKesson
QuintilesIMS
Teva
Fish and Richardson

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