Details for New Drug Application (NDA): 205675
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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 205675
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Eugia Pharma |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205675
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 205675
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 205675 | ANDA | Eugia US LLC | 55150-202 | 55150-202-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-202-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (55150-202-00) |
PANTOPRAZOLE SODIUM | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 205675 | ANDA | Eugia US LLC | 55150-202 | 55150-202-25 | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-202-25) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (55150-202-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 40MG BASE/VIAL | ||||
Approval Date: | Mar 30, 2016 | TE: | AP | RLD: | No |
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