Details for New Drug Application (NDA): 090970
✉ Email this page to a colleague
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 090970
Tradename: | PANTOPRAZOLE SODIUM |
Applicant: | Mylan Pharms Inc |
Ingredient: | pantoprazole sodium |
Patents: | 0 |
Pharmacology for NDA: 090970
Mechanism of Action | Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 090970
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 090970 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6688 | 0378-6688-77 | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6688-77) |
PANTOPRAZOLE SODIUM | pantoprazole sodium | TABLET, DELAYED RELEASE;ORAL | 090970 | ANDA | Mylan Pharmaceuticals Inc. | 0378-6689 | 0378-6689-10 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6689-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Jan 19, 2011 | 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 19, 2011 | TE: | AB | RLD: | No |
Complete Access Available with Subscription