Details for New Drug Application (NDA): 020987
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NDA 020987 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 020987
| Tradename: | PROTONIX |
| Applicant: | Wyeth Pharms |
| Ingredient: | pantoprazole sodium |
| Patents: | 0 |
Pharmacology for NDA: 020987
| Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 020987
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PROTONIX | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020987 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0841 | 0008-0841-81 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0841-81) |
| PROTONIX | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 020987 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-0843 | 0008-0843-81 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0843-81) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Feb 2, 2000 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jun 12, 2001 | TE: | AB | RLD: | Yes | ||||
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