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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. There are three patents protecting this drug. Additional details are available on the PROTONIX IV profile page.
The generic ingredient in PROTONIX IV is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Fifty-two 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 are forty-eight drug master file entries for this compound. Fifty-two 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: | 3 |
| Formulation / Manufacturing: | see details |
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;IV (INFUSION) | 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;IV (INFUSION) | 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 |
Paragraph IV (Patent) Challenges for 020988
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PROTONIX IV | INJECTABLE;IV (INFUSION) | pantoprazole sodium | 020988 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;IV (INFUSION) | Strength | EQ 40MG BASE/VIAL | ||||
| Approval Date: | Mar 22, 2001 | TE: | AP | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | May 17, 2022 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | Start Trial | Patent Expiration: | May 17, 2022 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | Start Trial | Patent Expiration: | May 17, 2022 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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;IV (INFUSION) | 020988-001 | Mar 22, 2001 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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