Details for New Drug Application (NDA): 217512
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NDA 217512 describes PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. Additional details are available on the PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE profile page.
The generic ingredient in PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE 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.
The generic ingredient in PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE 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 217512
| Tradename: | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE |
| Applicant: | Baxter Hlthcare Corp |
| Ingredient: | pantoprazole sodium |
| Patents: | 0 |
Pharmacology for NDA: 217512
| Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 217512
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | pantoprazole sodium | SOLUTION;INTRAVENOUS | 217512 | NDA | Baxter Healthcare Corporation | 0338-9644 | 0338-9644-12 | 12 BAG in 1 CARTON (0338-9644-12) / 100 mL in 1 BAG (0338-9644-01) |
| PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | pantoprazole sodium | SOLUTION;INTRAVENOUS | 217512 | NDA | Baxter Healthcare Corporation | 0338-9646 | 0338-9646-24 | 24 BAG in 1 CARTON (0338-9646-24) / 50 mL in 1 BAG (0338-9646-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) | ||||
| Approval Date: | Feb 14, 2024 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) | ||||
| Approval Date: | Feb 14, 2024 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) | ||||
| Approval Date: | Feb 14, 2024 | TE: | RLD: | Yes | |||||
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