Details for New Drug Application (NDA): 215732
NDA 215732 describes ESOMEPRAZOLE SODIUM, which is a drug marketed by Accord Hlthcare, Epic Pharma Llc, Eugia Pharma, Gland, Hainan Poly, Pharmobedient, Regcon Holdings, and Sun Pharm, and is included in eight NDAs. It is available from three suppliers. Additional details are available on the ESOMEPRAZOLE SODIUM profile page.
The generic ingredient in ESOMEPRAZOLE SODIUM is esomeprazole sodium. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the esomeprazole sodium profile page.
The generic ingredient in ESOMEPRAZOLE SODIUM is esomeprazole sodium. There is one drug master file entry for this compound. Three 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 |
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 | 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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