Details for New Drug Application (NDA): 021507
✉ Email this page to a colleague
NDA 021507 describes PREVACID NAPRAPAC 500 (COPACKAGED), which is a drug marketed by Takeda Pharms Na and is included in one NDA. Additional details are available on the PREVACID NAPRAPAC 500 (COPACKAGED) profile page.
The generic ingredient in PREVACID NAPRAPAC 500 (COPACKAGED) is lansoprazole; naproxen. There are fifty-six drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.
The generic ingredient in PREVACID NAPRAPAC 500 (COPACKAGED) is lansoprazole; naproxen. There are fifty-six drug master file entries for this compound. Additional details are available on the lansoprazole; naproxen profile page.
Summary for 021507
| Tradename: | PREVACID NAPRAPAC 500 (COPACKAGED) |
| Applicant: | Takeda Pharms Na |
| Ingredient: | lansoprazole; naproxen |
| Patents: | 0 |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | Strength | 15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Nov 14, 2003 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | Strength | 15MG,N/A;N/A,375MG | ||||
| Approval Date: | Nov 14, 2003 | TE: | RLD: | No | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS, TABLET;ORAL | Strength | 15MG,N/A;N/A,500MG | ||||
| Approval Date: | Nov 14, 2003 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
