Product Details for ANDA 205063
ISOTRETINOIN (ISOTRETINOIN)
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
35MG
Marketing Status: Prescription
40MG
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: A205063
Product Number: 001
Approval Date: Mar 31, 2021
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
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: A205063
Product Number: 001
Approval Date: Mar 31, 2021
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
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: A205063
Product Number: 002
Approval Date: Mar 31, 2021
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
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: A205063
Product Number: 002
Approval Date: Mar 31, 2021
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
25MG
Marketing Status: Prescription
Active Ingredient: ISOTRETINOIN
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A205063
Product Number: 003
Approval Date: Mar 31, 2021
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
ISOTRETINOIN (ISOTRETINOIN)
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A205063
Product Number: 003
Approval Date: Mar 31, 2021
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
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: A205063
Product Number: 004
Approval Date: Mar 31, 2021
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
ISOTRETINOIN (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: A205063
Product Number: 004
Approval Date: Mar 31, 2021
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
35MG
Marketing Status: Prescription
Active Ingredient: ISOTRETINOIN
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 35MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A205063
Product Number: 005
Approval Date: Mar 31, 2021
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
ISOTRETINOIN (ISOTRETINOIN)
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 35MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A205063
Product Number: 005
Approval Date: Mar 31, 2021
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: AB2
Application Number: A205063
Product Number: 006
Approval Date: Mar 31, 2021
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ISOTRETINOIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A205063
Product Number: 006
Approval Date: Mar 31, 2021
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information