DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076135

« Back to Dashboard

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

Ingredient-type

Retinoids

Medical Subject Heading (MeSH) Categories for 076135

Dermatologic Agents

Teratogens

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:	RX	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	Apr 11, 2003	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	20MG
Approval Date:	Apr 11, 2003	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	May 11, 2006	TE:	AB	RLD:	No

Complete Access Available with Subscription