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Generated: September 24, 2018

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Details for New Drug Application (NDA): 204118

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NDA 204118 describes INDOMETHACIN SODIUM, which is a drug marketed by Hospira Inc, Navinta Llc, and West-ward Pharms Int, and is included in three NDAs. It is available from two suppliers. Additional details are available on the INDOMETHACIN SODIUM profile page.

The generic ingredient in INDOMETHACIN SODIUM is indomethacin sodium. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the indomethacin sodium profile page.
Summary for 204118
Applicant:Hospira Inc
Ingredient:indomethacin sodium
Formulation / Manufacturing:see details
Pharmacology for NDA: 204118
Suppliers and Packaging for NDA: 204118
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INDOMETHACIN SODIUM indomethacin sodium INJECTABLE;INJECTION 204118 ANDA Hospira, Inc. 0409-1113 0409-1113-01 1 VIAL, SINGLE-USE in 1 CARTON (0409-1113-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

Profile for product number 001

Approval Date:Apr 19, 2016TE:APRLD:No

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