Details for New Drug Application (NDA): 020988
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The generic ingredient in PROTONIX IV 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 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 |
Expired US Patents for NDA 020988
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Wyeth Pharms | PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988-001 | Mar 22, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Wyeth Pharms | PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988-001 | Mar 22, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Wyeth Pharms | PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988-001 | Mar 22, 2001 | ⤷ Sign Up | ⤷ Sign Up |
Wyeth Pharms | PROTONIX IV | pantoprazole sodium | INJECTABLE;INTRAVENOUS | 020988-001 | Mar 22, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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