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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 062628

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NDA 062628 describes CHLORAMPHENICOL, which is a drug marketed by Elkins Sinn, Altana, Alcon, Epic Pharma Llc, Fresenius Kabi Usa, and Gruppo Lepetit, and is included in six NDAs. Additional details are available on the CHLORAMPHENICOL profile page.

The generic ingredient in CHLORAMPHENICOL is chloramphenicol. There are fourteen drug master file entries for this compound. Additional details are available on the chloramphenicol profile page.

Summary for 062628

Tradename:	CHLORAMPHENICOL
Applicant:	Alcon
Ingredient:	chloramphenicol
Patents:	0

Medical Subject Heading (MeSH) Categories for 062628

Anti-Bacterial Agents
Protein Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	Sep 25, 1985	TE:		RLD:	No

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