Details for New Drug Application (NDA): 216655
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NDA 216655 describes OPIPZA, which is a drug marketed by Xiamen Lp Pharm Co and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the OPIPZA profile page.
The generic ingredient in OPIPZA is aripiprazole. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
The generic ingredient in OPIPZA is aripiprazole. There is one drug master file entry for this compound. Fifty suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.
Summary for 216655
| Tradename: | OPIPZA |
| Applicant: | Xiamen Lp Pharm Co |
| Ingredient: | aripiprazole |
| Patents: | 2 |
Suppliers and Packaging for NDA: 216655
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OPIPZA | aripiprazole | FILM;ORAL | 216655 | NDA | Carwin Pharmaceutical Associates, LLC | 15370-401 | 15370-401-30 | 30 POUCH in 1 CARTON (15370-401-30) / 1 FILM, SOLUBLE in 1 POUCH (15370-401-01) |
| OPIPZA | aripiprazole | FILM;ORAL | 216655 | NDA | Carwin Pharmaceutical Associates, LLC | 15370-401 | 15370-401-99 | 2 POUCH in 1 CARTON (15370-401-99) / 1 FILM, SOLUBLE in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;ORAL | Strength | 2MG | ||||
| Approval Date: | Jul 22, 2024 | TE: | RLD: | Yes | |||||
| Patent: | 11,331,315 | Patent Expiration: | Nov 3, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,701,352 | Patent Expiration: | Dec 15, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM;ORAL | Strength | 5MG | ||||
| Approval Date: | Jul 22, 2024 | TE: | RLD: | Yes | |||||
| Patent: | 11,331,315 | Patent Expiration: | Nov 3, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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