Details for New Drug Application (NDA): 021729
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NDA 021729 describes ABILIFY, which is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in seven NDAs. It is available from one supplier. There are forty-six patents protecting this drug and three Paragraph IV challenges. Additional details are available on the ABILIFY profile page.
The generic ingredient in ABILIFY 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 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 021729
| Tradename: | ABILIFY |
| Applicant: | Otsuka |
| Ingredient: | aripiprazole |
| Patents: | 3 |
Medical Subject Heading (MeSH) Categories for 021729
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jun 7, 2006 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 16, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 2, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 28, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ACUTE TREATMENT OF MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER | ||||||||
Expired US Patents for NDA 021729
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-003 | Jun 7, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-002 | Jun 7, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-003 | Jun 7, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-004 | Jun 7, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-003 | Jun 7, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-004 | Jun 7, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka | ABILIFY | aripiprazole | TABLET, ORALLY DISINTEGRATING;ORAL | 021729-005 | Jun 7, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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