Details for New Drug Application (NDA): 202882
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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 suppliers are listed for this compound. Additional details are available on the pantoprazole sodium profile page.
Summary for 202882
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Hetero Labs Ltd V |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Pharmacology for NDA: 202882
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 202882
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 202882 | ANDA | Camber Pharmaceuticals, Inc. | 31722-712 | 31722-712-31 | 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (31722-712-31) |
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 202882 | ANDA | Camber Pharmaceuticals, Inc. | 31722-712 | 31722-712-32 | 10 TABLET, DELAYED RELEASE in 1 CARTON (31722-712-32) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Sep 10, 2014 | 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: | Sep 10, 2014 | TE: | AB | RLD: | No |
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