Details for New Drug Application (NDA): 216171
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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 216171
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Be Pharms |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Pharmacology for NDA: 216171
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 216171
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 216171 | ANDA | BE Pharmaceuticals Inc. | 71839-122 | 71839-122-01 | 1 VIAL in 1 CARTON (71839-122-01) / 10 mL in 1 VIAL |
PANTOPRAZOLE SODIUM | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 216171 | ANDA | BE Pharmaceuticals Inc. | 71839-122 | 71839-122-10 | 10 CARTON in 1 PACKAGE (71839-122-10) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 40MG BASE/VIAL | ||||
Approval Date: | May 18, 2022 | TE: | AP | RLD: | No |
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