Details for New Drug Application (NDA): 077056
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The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 077056
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Teva |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Pharmacology for NDA: 077056
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 077056
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 077056 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-343 | 43353-343-30 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-343-30) |
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 077056 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-343 | 43353-343-53 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-343-53) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Aug 2, 2007 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Aug 2, 2007 | TE: | RLD: | No |
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