Details for New Drug Application (NDA): 211752
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The generic ingredient in ESOMEPRAZOLE MAGNESIUM is esomeprazole magnesium. There are seventy-four drug master file entries for this compound. One hundred and thirteen suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 211752
Tradename: | ESOMEPRAZOLE MAGNESIUM |
Applicant: | Cipla |
Ingredient: | esomeprazole magnesium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 211752
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 211752
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 211752 | ANDA | Cipla USA Inc. | 69097-527 | 69097-527-34 | 30 GRANULE, FOR SUSPENSION, EXTENDED RELEASE in 1 CARTON (69097-527-34) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 10MG BASE/PACKET | ||||
Approval Date: | Mar 23, 2020 | TE: | AB | RLD: | No |
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