Details for New Drug Application (NDA): 078281
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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 078281
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Lannett Co Inc |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078281
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 078281
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 078281 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-027 | 43353-027-30 | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-30) |
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 078281 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-027 | 43353-027-53 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (43353-027-53) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Jan 20, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Jan 20, 2011 | TE: | AB | RLD: | No |
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