Details for New Drug Application (NDA): 217282
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The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 217282
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Granules |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 217282
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 217282
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 217282 | ANDA | Granules Pharmaceuticals Inc. | 70010-190 | 70010-190-09 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (70010-190-09) |
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 217282 | ANDA | Granules Pharmaceuticals Inc. | 70010-190 | 70010-190-10 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (70010-190-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Dec 11, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Dec 11, 2023 | TE: | AB | RLD: | No |
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