Details for New Drug Application (NDA): 219087
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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 219087
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Graviti Pharms |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Pharmacology for NDA: 219087
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 219087
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 219087 | ANDA | Rising Pharma Holdings, Inc. | 64980-676 | 64980-676-09 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (64980-676-09) |
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 219087 | ANDA | Rising Pharma Holdings, Inc. | 64980-677 | 64980-677-09 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (64980-677-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Jan 16, 2025 | 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: | Jan 16, 2025 | TE: | AB | RLD: | No |
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