Details for New Drug Application (NDA): 217416
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The generic ingredient in PANTOPRAZOLE SODIUM is pantoprazole sodium. There are forty-eight drug master file entries for this compound. Seventy-one suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 217416
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Pharmacology for NDA: 217416
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 217416
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 217416 | ANDA | Ajanta Pharma USA Inc. | 27241-256 | 27241-256-11 | 1 FOR SUSPENSION in 1 PACKET (27241-256-11) |
PANTOPRAZOLE SODIUM | pantoprazole sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 217416 | ANDA | Ajanta Pharma USA Inc. | 27241-256 | 27241-256-38 | 30 FOR SUSPENSION in 1 CARTON (27241-256-38) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Feb 9, 2023 | TE: | AB | RLD: | No |
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