Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207792

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ISOTRETINOIN (ISOTRETINOIN)
10MG
Marketing Status: Prescription

Active Ingredient: ISOTRETINOIN
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A207792
Product Number: 001
Approval Date: Sep 29, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ISOTRETINOIN (ISOTRETINOIN)
20MG
Marketing Status: Prescription

Active Ingredient: ISOTRETINOIN
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A207792
Product Number: 002
Approval Date: Sep 29, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ISOTRETINOIN (ISOTRETINOIN)
30MG
Marketing Status: Prescription

Active Ingredient: ISOTRETINOIN
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A207792
Product Number: 003
Approval Date: Sep 29, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ISOTRETINOIN (ISOTRETINOIN)
40MG
Marketing Status: Prescription

Active Ingredient: ISOTRETINOIN
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB1
Application Number: A207792
Product Number: 004
Approval Date: Sep 29, 2017
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS OF NY LLC
Marketing Status:  Prescription
Patent and Exclusivity Information