Details for New Drug Application (NDA): 217006
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NDA 217006 describes ABILIFY ASIMTUFII, which is a drug marketed by Otsuka and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the ABILIFY ASIMTUFII profile page.
The generic ingredient in ABILIFY ASIMTUFII is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
The generic ingredient in ABILIFY ASIMTUFII is aripiprazole. There are forty-nine drug master file entries for this compound. Forty-seven 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: | ⤷ Try a Trial | Patent Expiration: | Apr 23, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 23, 2033 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF SCHIZOPHRENIA | ||||||||
| Patent: | ⤷ Try a Trial | 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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Otsuka | ABILIFY ASIMTUFII | aripiprazole | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 217006-001 | Apr 27, 2023 | ⤷ Try a Trial | ⤷ Try a Trial |
| Otsuka | ABILIFY ASIMTUFII | aripiprazole | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 217006-002 | Apr 27, 2023 | ⤷ Try a Trial | ⤷ Try a Trial |
| Otsuka | ABILIFY ASIMTUFII | aripiprazole | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 217006-002 | Apr 27, 2023 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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