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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 Pharma Inc and Igi Labs 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. Three suppliers are listed for this compound. Additional details are available on the cefotetan disodium profile page.

Summary for NDA: 050588

Teligent Pharma Inc
cefotetan disodium

Pharmacology for NDA: 050588


Suppliers and Packaging for NDA: 050588

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary for product number 001

Approval Date:Dec 27, 1985TE:APRLD:No

Summary for product number 002

Approval Date:Dec 27, 1985TE:APRLD:No

Summary for product number 003

Approval Date:Apr 25, 1988TE:RLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.