Product Details for ANDA 212333
ISOTRETINOIN (ISOTRETINOIN)
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
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: AB2
Application Number: A212333
Product Number: 001
Approval Date: Sep 21, 2021
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ISOTRETINOIN (ISOTRETINOIN)
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A212333
Product Number: 001
Approval Date: Sep 21, 2021
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
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: AB2
Application Number: A212333
Product Number: 002
Approval Date: Sep 21, 2021
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ISOTRETINOIN (ISOTRETINOIN)
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A212333
Product Number: 002
Approval Date: Sep 21, 2021
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
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: AB2
Application Number: A212333
Product Number: 003
Approval Date: Sep 21, 2021
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A212333
Product Number: 003
Approval Date: Sep 21, 2021
Applicant Holder Full Name: UPSHER SMITH LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information