Details for New Drug Application (NDA): 206055
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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 twelve suppliers are listed for this compound. Additional details are available on the esomeprazole magnesium profile page.
Summary for 206055
Tradename: | ESOMEPRAZOLE MAGNESIUM |
Applicant: | Zydus Pharms |
Ingredient: | esomeprazole magnesium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206055
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 206055
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 206055 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-848 | 68382-848-94 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (68382-848-94) |
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 206055 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-849 | 68382-849-94 | 30 GRANULE, DELAYED RELEASE in 1 CARTON (68382-849-94) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 20MG BASE/PACKET | ||||
Approval Date: | Jun 7, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, DELAYED RELEASE;ORAL | Strength | EQ 40MG BASE/PACKET | ||||
Approval Date: | Jun 7, 2023 | TE: | AB | RLD: | No |
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