Details for New Drug Application (NDA): 202971
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The generic ingredient in ABILIFY MAINTENA KIT 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 202971
Tradename: | ABILIFY MAINTENA KIT |
Applicant: | Otsuka Pharm Co Ltd |
Ingredient: | aripiprazole |
Patents: | 11 |
Medical Subject Heading (MeSH) Categories for 202971
Suppliers and Packaging for NDA: 202971
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971 | NDA | Otsuka America Pharmaceutical, Inc. | 59148-018 | 59148-018-71 | 1 KIT in 1 CARTON (59148-018-71) * 1.5 mL in 1 VIAL, SINGLE-USE * 5 mL in 1 VIAL, SINGLE-USE |
ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971 | NDA | Otsuka America Pharmaceutical, Inc. | 59148-019 | 59148-019-71 | 1 KIT in 1 CARTON (59148-019-71) * 1.9 mL in 1 VIAL, SINGLE-USE * 5 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 300MG/VIAL | ||||
Approval Date: | Feb 28, 2013 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 8, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR 1 DISORDER | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 8, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF SCHIZOPHRENIA | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 8, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA |
Expired US Patents for NDA 202971
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-001 | Feb 28, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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