Details for New Drug Application (NDA): 211368
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The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 211368
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Ingenus Pharms Llc |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Pharmacology for NDA: 211368
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 211368
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 211368 | ANDA | AvKARE | 42291-765 | 42291-765-10 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-765-10) |
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 211368 | ANDA | AvKARE | 42291-765 | 42291-765-90 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-765-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Mar 1, 2019 | TE: | AB | RLD: | No |
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