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

Summary for NDA: 076135

Teva Pharms Usa
Therapeutic Class:Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076135


Suppliers and Packaging for NDA: 076135

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
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:Yes

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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