Details for New Drug Application (NDA): 213778
✉ Email this page to a colleague
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 213778
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Aspiro |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213778
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 213778
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 213778 | ANDA | Camber Pharmaceuticals, Inc. | 31722-204 | 31722-204-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-204-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (31722-204-31) |
PANTOPRAZOLE SODIUM | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 213778 | ANDA | Camber Pharmaceuticals, Inc. | 31722-204 | 31722-204-32 | 25 VIAL, SINGLE-DOSE in 1 CARTON (31722-204-32) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (31722-204-31) |
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 |
Complete Access Available with Subscription