Details for New Drug Application (NDA): 205606
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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 205606
Tradename: | ESOMEPRAZOLE MAGNESIUM |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | esomeprazole magnesium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 205606
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 205606
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 205606 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8396 | 0615-8396-39 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8396-39) |
ESOMEPRAZOLE MAGNESIUM | esomeprazole magnesium | CAPSULE, DELAYED REL PELLETS;ORAL | 205606 | ANDA | medsourcer pharmaceuticals | 45865-892 | 45865-892-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-892-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Apr 21, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Apr 21, 2016 | TE: | AB | RLD: | No |
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