Details for New Drug Application (NDA): 215732
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The generic ingredient in ESOMEPRAZOLE SODIUM is esomeprazole sodium. There are seventy-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
Summary for 215732
Tradename: | ESOMEPRAZOLE SODIUM |
Applicant: | Hainan Poly |
Ingredient: | esomeprazole sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 215732
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Suppliers and Packaging for NDA: 215732
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 215732 | ANDA | Hainan Poly Pharm. Co., Ltd. | 14335-060 | 14335-060-01 | 10 VIAL in 1 CARTON (14335-060-01) / 5 mL in 1 VIAL |
ESOMEPRAZOLE SODIUM | esomeprazole sodium | INJECTABLE;INTRAVENOUS | 215732 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-190 | 70436-190-82 | 10 VIAL in 1 CARTON (70436-190-82) / 5 mL in 1 VIAL (70436-190-80) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | EQ 40MG BASE/VIAL | ||||
Approval Date: | Feb 10, 2022 | TE: | AP | RLD: | No |
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