Product Details for NDA 207202
ABILIFY MYCITE KIT (ARIPIPRAZOLE)
2MG
Marketing Status: Discontinued
5MG
Marketing Status: Discontinued
10MG
Marketing Status: Discontinued
15MG
Marketing Status: Discontinued
20MG
Marketing Status: Discontinued
30MG
Marketing Status: Discontinued
2MG
Marketing Status: Discontinued
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY MYCITE KIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207202
Product Number: 001
Approval Date: Nov 13, 2017
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
ABILIFY MYCITE KIT (ARIPIPRAZOLE)
Proprietary Name: ABILIFY MYCITE KIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207202
Product Number: 001
Approval Date: Nov 13, 2017
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG
Marketing Status: Discontinued
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY MYCITE KIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207202
Product Number: 002
Approval Date: Nov 13, 2017
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
ABILIFY MYCITE KIT (ARIPIPRAZOLE)
Proprietary Name: ABILIFY MYCITE KIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207202
Product Number: 002
Approval Date: Nov 13, 2017
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG
Marketing Status: Discontinued
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY MYCITE KIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207202
Product Number: 003
Approval Date: Nov 13, 2017
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
ABILIFY MYCITE KIT (ARIPIPRAZOLE)
Proprietary Name: ABILIFY MYCITE KIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207202
Product Number: 003
Approval Date: Nov 13, 2017
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
15MG
Marketing Status: Discontinued
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY MYCITE KIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207202
Product Number: 004
Approval Date: Nov 13, 2017
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
ABILIFY MYCITE KIT (ARIPIPRAZOLE)
Proprietary Name: ABILIFY MYCITE KIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207202
Product Number: 004
Approval Date: Nov 13, 2017
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
20MG
Marketing Status: Discontinued
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY MYCITE KIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207202
Product Number: 005
Approval Date: Nov 13, 2017
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
ABILIFY MYCITE KIT (ARIPIPRAZOLE)
Proprietary Name: ABILIFY MYCITE KIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207202
Product Number: 005
Approval Date: Nov 13, 2017
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
30MG
Marketing Status: Discontinued
Active Ingredient: ARIPIPRAZOLE
Proprietary Name: ABILIFY MYCITE KIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207202
Product Number: 006
Approval Date: Nov 13, 2017
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ABILIFY MYCITE KIT
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207202
Product Number: 006
Approval Date: Nov 13, 2017
Applicant Holder Full Name: OTSUKA PHARMACEUTICAL CO LTD
Marketing Status: Discontinued
Patent and Exclusivity Information