Application 202971
- Type
- NDA
- Sponsor
- OTSUKA PHARM CO LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ABILIFY MAINTENA KIT | ARIPIPRAZOLE | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 300MG/VIAL | Yes | No |
| 002 | ABILIFY MAINTENA KIT | ARIPIPRAZOLE | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 400MG/VIAL | Yes | Yes |
| 003 | ABILIFY MAINTENA KIT | ARIPIPRAZOLE | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 300MG | Yes | No |
| 004 | ABILIFY MAINTENA KIT | ARIPIPRAZOLE | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 400MG | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59148-018 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-018 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-018 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-018 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-018 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-019 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-019 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-019 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-019 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-019 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-045 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-045 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-045 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-045 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-045 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-072 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-072 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-072 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-072 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-072 | ABILIFY MAINTENA | aripiprazole | Otsuka America Pharmaceutical, Inc. | NDA | Current |