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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 064134


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NDA 064134 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 eight 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 064134
Pharmacology for NDA: 064134
Suppliers and Packaging for NDA: 064134
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TOBRAMYCIN AND DEXAMETHASONE dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 064134 ANDA Bausch & Lomb Incorporated 24208-295 24208-295-05 1 BOTTLE, DROPPER in 1 CARTON (24208-295-05) / 5 mL in 1 BOTTLE, DROPPER
TOBRAMYCIN AND DEXAMETHASONE dexamethasone; tobramycin SUSPENSION/DROPS;OPHTHALMIC 064134 ANDA Bausch & Lomb Incorporated 24208-295 24208-295-10 1 BOTTLE, DROPPER in 1 CARTON (24208-295-10) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.1%;0.3%
Approval Date:Oct 27, 1999TE:ABRLD:No

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