Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076135

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CLARAVIS (ISOTRETINOIN)
20MG
Marketing Status: Prescription

Active Ingredient: ISOTRETINOIN
Proprietary Name: CLARAVIS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A076135
Product Number: 002
Approval Date: Apr 11, 2003
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

CLARAVIS (ISOTRETINOIN)
30MG
Marketing Status: Prescription

Active Ingredient: ISOTRETINOIN
Proprietary Name: CLARAVIS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A076135
Product Number: 003
Approval Date: May 11, 2006
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information

CLARAVIS (ISOTRETINOIN)
40MG
Marketing Status: Prescription

Active Ingredient: ISOTRETINOIN
Proprietary Name: CLARAVIS
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB1
Application Number: A076135
Product Number: 001
Approval Date: Apr 11, 2003
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status:  Prescription
Patent and Exclusivity Information