Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076041

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SOTRET (ISOTRETINOIN)
10MG
Marketing Status: Discontinued

Active Ingredient: ISOTRETINOIN
Proprietary Name: SOTRET
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076041
Product Number: 001
Approval Date: Dec 24, 2002
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

SOTRET (ISOTRETINOIN)
20MG
Marketing Status: Discontinued

Active Ingredient: ISOTRETINOIN
Proprietary Name: SOTRET
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076041
Product Number: 002
Approval Date: Dec 24, 2002
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

SOTRET (ISOTRETINOIN)
40MG
Marketing Status: Discontinued

Active Ingredient: ISOTRETINOIN
Proprietary Name: SOTRET
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A076041
Product Number: 003
Approval Date: Dec 24, 2002
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information