Details for New Drug Application (NDA): 202971
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NDA 202971 describes ABILIFY MAINTENA KIT, which is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the ABILIFY MAINTENA KIT profile page.
The generic ingredient in ABILIFY MAINTENA KIT is aripiprazole. There are forty-nine drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
The generic ingredient in ABILIFY MAINTENA KIT is aripiprazole. There are forty-nine drug master file entries for this compound. Fifty 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: | 10,525,057 | Patent Expiration: | Mar 8, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR 1 DISORDER | ||||||||
| Patent: | 10,525,057 | Patent Expiration: | Mar 8, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SCHIZOPHRENIA | ||||||||
| Patent: | 10,525,057 | 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 | 202971-003 | Sep 29, 2014 | 8,759,351 | ⤷ Subscribe |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | 8,759,351 | ⤷ Subscribe |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-003 | Sep 29, 2014 | 8,030,313 | ⤷ Subscribe |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-003 | Sep 29, 2014 | 9,089,567 | ⤷ Subscribe |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-004 | Sep 29, 2014 | 8,993,761 | ⤷ Subscribe |
| Otsuka Pharm Co Ltd | ABILIFY MAINTENA KIT | aripiprazole | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 202971-002 | Feb 28, 2013 | 8,338,428 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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