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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 061453

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NDA 061453 describes TEGOPEN, which is a drug marketed by Apothecon and is included in two NDAs. Additional details are available on the TEGOPEN profile page.

The generic ingredient in TEGOPEN is cloxacillin sodium. There are twenty-three drug master file entries for this compound. Additional details are available on the cloxacillin sodium profile page.

Summary for 061453

Tradename:	TEGOPEN
Applicant:	Apothecon
Ingredient:	cloxacillin sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 061453

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;ORAL			Strength	EQ 125MG BASE/5ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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