Details for New Drug Application (NDA): 216247
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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 216247
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Dexcel |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Pharmacology for NDA: 216247
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 216247
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 216247 | ANDA | Edenbridge Pharmaceuticals LLC. | 42799-952 | 42799-952-30 | 30 PACKET in 1 CARTON (42799-952-30) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (42799-952-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Jun 16, 2023 | TE: | AB | RLD: | No |
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