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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 212991

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NDA 212991 describes TOBRAMYCIN AND DEXAMETHASONE, which is a drug marketed by Amneal, Bausch And Lomb, and Padagis Us, and is included in three NDAs. It is available from seven suppliers. Additional details are available on the TOBRAMYCIN AND DEXAMETHASONE profile page.

The generic ingredient in TOBRAMYCIN AND DEXAMETHASONE is dexamethasone; tobramycin. There are thirty-nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dexamethasone; tobramycin profile page.

Summary for 212991

Tradename:	TOBRAMYCIN AND DEXAMETHASONE
Applicant:	Amneal
Ingredient:	dexamethasone; tobramycin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.1%;0.3%
Approval Date:	Jul 15, 2021	TE:		RLD:	No

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