Details for New Drug Application (NDA): 020988
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NDA 020988 describes PROTONIX IV, which is a drug marketed by Wyeth Pharms and is included in one NDA. It is available from two suppliers. Additional details are available on the PROTONIX IV profile page.
The generic ingredient in PROTONIX IV is pantoprazole sodium. There is one drug master file entry for this compound. Seventy suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
The generic ingredient in PROTONIX IV is pantoprazole sodium. There is one drug master file entry for this compound. Seventy suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 020988
| Tradename: | PROTONIX IV |
| Applicant: | Wyeth Pharms |
| Ingredient: | pantoprazole sodium |
| Patents: | 0 |
Pharmacology for NDA: 020988
| Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 020988
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0923 | 0008-0923-51 | 1 VIAL in 1 CARTON (0008-0923-51) / 10 mL in 1 VIAL |
| PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0923 | 0008-0923-55 | 10 CARTON in 1 PACKAGE (0008-0923-55) / 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: | Mar 22, 2001 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Aug 12, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
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