Details for New Drug Application (NDA): 090296
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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 090296
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Sandoz |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090296
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 090296
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 090296 | ANDA | Teva Pharmaceuticals USA, Inc. | 0480-4111 | 0480-4111-03 | 10 VIAL in 1 CARTON (0480-4111-03) / 10 mL in 1 VIAL (0480-4111-01) |
PANTOPRAZOLE SODIUM | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 090296 | ANDA | Sandoz Inc | 0781-3232 | 0781-3232-95 | 10 VIAL in 1 CARTON (0781-3232-95) / 10 mL in 1 VIAL (0781-3232-94) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 40MG BASE/VIAL | ||||
Approval Date: | Jul 14, 2015 | TE: | AP | RLD: | No |
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