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Details for New Drug Application (NDA): 205379

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NDA 205379 describes ESOMEPRAZOLE SODIUM, which is a drug marketed by Aurobindo Pharma Ltd, Accord Hlthcare, and Sun Pharma Global, and is included in three NDAs. It is available from four suppliers. Additional details are available on the ESOMEPRAZOLE SODIUM profile page.

The generic ingredient in ESOMEPRAZOLE SODIUM is esomeprazole sodium. There are sixty-five drug master file entries for this compound. Six suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the esomeprazole sodium profile page.

Summary for NDA: 205379

Tradename:
ESOMEPRAZOLE SODIUM
Applicant:
Accord Hlthcare
Ingredient:
esomeprazole sodium
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 205379

Suppliers and Packaging for NDA: 205379

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESOMEPRAZOLE SODIUM
esomeprazole sodium
INJECTABLE;INTRAVENOUS 205379 ANDA Accord Healthcare Inc. 16729-252 16729-252-66 1 VIAL in 1 CARTON (16729-252-66) > 5 mL in 1 VIAL
ESOMEPRAZOLE SODIUM
esomeprazole sodium
INJECTABLE;INTRAVENOUS 205379 ANDA Accord Healthcare Inc. 16729-252 16729-252-69 10 VIAL in 1 CARTON (16729-252-69) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 40MG BASE/VIAL
Approval Date:Sep 25, 2015TE:APRLD:No


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