Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075945

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AMNESTEEM (ISOTRETINOIN)
10MG
Marketing Status: Prescription

Active Ingredient: ISOTRETINOIN
Proprietary Name: AMNESTEEM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A075945
Product Number: 001
Approval Date: Nov 8, 2002
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AMNESTEEM (ISOTRETINOIN)
20MG
Marketing Status: Prescription

Active Ingredient: ISOTRETINOIN
Proprietary Name: AMNESTEEM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A075945
Product Number: 002
Approval Date: Nov 8, 2002
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

AMNESTEEM (ISOTRETINOIN)
40MG
Marketing Status: Prescription

Active Ingredient: ISOTRETINOIN
Proprietary Name: AMNESTEEM
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A075945
Product Number: 003
Approval Date: Nov 8, 2002
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information