Details for New Drug Application (NDA): 217006
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The generic ingredient in ABILIFY ASIMTUFII is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 217006
Tradename: | ABILIFY ASIMTUFII |
Applicant: | Otsuka |
Ingredient: | aripiprazole |
Patents: | 5 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 217006
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABILIFY ASIMTUFII | aripiprazole | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 217006 | NDA | Otsuka America Pharmaceutical, Inc | 59148-102 | 59148-102-80 | 1 SYRINGE in 1 CARTON (59148-102-80) / 2.4 mL in 1 SYRINGE |
ABILIFY ASIMTUFII | aripiprazole | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 217006 | NDA | Otsuka America Pharmaceutical, Inc | 59148-114 | 59148-114-80 | 1 SYRINGE in 1 CARTON (59148-114-80) / 3.2 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 720MG/2.4ML (300MG/ML) | ||||
Approval Date: | Apr 27, 2023 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 23, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 23, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF SCHIZOPHRENIA | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 23, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER |
Expired US Patents for NDA 217006
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Otsuka | ABILIFY ASIMTUFII | aripiprazole | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 217006-001 | Apr 27, 2023 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | ABILIFY ASIMTUFII | aripiprazole | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 217006-002 | Apr 27, 2023 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | ABILIFY ASIMTUFII | aripiprazole | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 217006-002 | Apr 27, 2023 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka | ABILIFY ASIMTUFII | aripiprazole | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 217006-001 | Apr 27, 2023 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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