Details for New Drug Application (NDA): 213725
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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 213725
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Sun Pharm |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Pharmacology for NDA: 213725
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 213725
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 213725 | ANDA | Sun Pharmaceutical Industries, Inc. | 62756-071 | 62756-071-64 | 30 PACKET in 1 CARTON (62756-071-64) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (62756-071-60) |
PANTOPRAZOLE SODIUM | pantoprazole sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 213725 | ANDA | NorthStar RxLLC | 72603-317 | 72603-317-30 | 30 PACKET in 1 CARTON (72603-317-30) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (72603-317-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Jun 30, 2020 | TE: | AB | RLD: | No |
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