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Last Updated: July 10, 2020

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Details for New Drug Application (NDA): 091031


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NDA 091031 describes CEFOTETAN, which is a drug marketed by Fresenius Kabi Usa, Hikma, West-ward Pharm Corp, and B Braun, and is included in five NDAs. It is available from two suppliers. Additional details are available on the CEFOTETAN profile page.

The generic ingredient in CEFOTETAN is cefotetan disodium. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the cefotetan disodium profile page.
Summary for 091031
Tradename:CEFOTETAN
Applicant:Hikma
Ingredient:cefotetan disodium
Patents:0
Pharmacology for NDA: 091031
Medical Subject Heading (MeSH) Categories for 091031
Suppliers and Packaging for NDA: 091031
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFOTETAN cefotetan disodium INJECTABLE;INJECTION 091031 ANDA Hikma Pharmaceuticals USA Inc. 0143-9670 0143-9670-10 10 VIAL in 1 CARTON (0143-9670-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9670-01)
CEFOTETAN cefotetan disodium INJECTABLE;INJECTION 091031 ANDA Hikma Pharmaceuticals USA Inc. 0143-9671 0143-9671-10 10 VIAL in 1 CARTON (0143-9671-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (0143-9671-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Oct 26, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Oct 26, 2011TE:APRLD:No

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