Details for New Drug Application (NDA): 022020
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NDA 022020 describes PROTONIX, which is a drug marketed by Wyeth Pharms and is included in three NDAs. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the PROTONIX profile page.
The generic ingredient in PROTONIX 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 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 022020
| Tradename: | PROTONIX |
| Applicant: | Wyeth Pharms |
| Ingredient: | pantoprazole sodium |
| Patents: | 1 |
Pharmacology for NDA: 022020
| Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 022020
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROTONIX | pantoprazole sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022020 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0844 | 0008-0844-02 | 30 PACKET in 1 CARTON (0008-0844-02) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (0008-0844-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Nov 14, 2007 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 7, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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