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Generated: November 12, 2018

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Details for New Drug Application (NDA): 050588

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NDA 050588 describes CEFOTAN, which is a drug marketed by Teligent and Teligent Pharma Inc and is included in three NDAs. It is available from one supplier. Additional details are available on the CEFOTAN profile page.

The generic ingredient in CEFOTAN 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 050588
Tradename:CEFOTAN
Applicant:Teligent
Ingredient:cefotetan disodium
Patents:0
Pharmacology for NDA: 050588
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 050588
Suppliers and Packaging for NDA: 050588
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFOTAN cefotetan disodium INJECTABLE;INJECTION 050588 NDA Teligent Pharma, Inc. 52565-052 52565-052-10 10 VIAL in 1 TRAY (52565-052-10) > 10 mL in 1 VIAL
CEFOTAN cefotetan disodium INJECTABLE;INJECTION 050588 NDA Teligent Pharma, Inc. 52565-053 52565-053-10 10 VIAL in 1 TRAY (52565-053-10) > 20 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 27, 1985TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Dec 27, 1985TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:Apr 25, 1988TE:RLD:No

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