Details for New Drug Application (NDA): 022327
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NDA 022327 describes PREVACID 24 HR, which is a drug marketed by Perrigo Pharma Intl and is included in one NDA. It is available from one supplier. Additional details are available on the PREVACID 24 HR profile page.
The generic ingredient in PREVACID 24 HR is lansoprazole. There are fifty-six drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the lansoprazole profile page.
The generic ingredient in PREVACID 24 HR is lansoprazole. There are fifty-six drug master file entries for this compound. Seventy suppliers are listed for this compound. Additional details are available on the lansoprazole profile page.
Summary for 022327
| Tradename: | PREVACID 24 HR |
| Applicant: | Perrigo Pharma Intl |
| Ingredient: | lansoprazole |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022327
| Mechanism of Action | Proton Pump Inhibitors |
| Physiological Effect | Inhibition Gastric Acid Secretion |
Medical Subject Heading (MeSH) Categories for 022327
Suppliers and Packaging for NDA: 022327
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREVACID 24 HR | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 022327 | NDA | L. Perrigo Company | 0113-6002 | 0113-6002-01 | 1 BOTTLE in 1 CARTON (0113-6002-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
| PREVACID 24 HR | lansoprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 022327 | NDA | L. Perrigo Company | 0113-6002 | 0113-6002-03 | 3 BOTTLE in 1 CARTON (0113-6002-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | 15MG | ||||
| Approval Date: | May 18, 2009 | TE: | RLD: | Yes | |||||
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