Details for New Drug Application (NDA): 206965

NDA 206965 describes TOBRAMYCIN SULFATE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Igi Labs Inc, Mylan Labs Ltd, Slate Run Pharma, Teva Pharms Usa, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in thirty-two NDAs. It is available from eleven suppliers. Additional details are available on the TOBRAMYCIN SULFATE profile page.

The generic ingredient in TOBRAMYCIN SULFATE is tobramycin sulfate. There are eighteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the tobramycin sulfate profile page.

Summary for 206965

Tradename:	TOBRAMYCIN SULFATE
Applicant:	Baxter Hlthcare Corp
Ingredient:	tobramycin sulfate
Patents:	0

Pharmacology for NDA: 206965

Suppliers and Packaging for NDA: 206965

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	206965	ANDA	Baxter Healthcare Corporation	36000-242	36000-242-01	1 VIAL, MULTI-DOSE in 1 CARTON (36000-242-01) / 30 mL in 1 VIAL, MULTI-DOSE
TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	206965	ANDA	Baxter Healthcare Corporation	36000-244	36000-244-25	25 VIAL, MULTI-DOSE in 1 BLISTER PACK (36000-244-25) / 2 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 40MG BASE/ML
Approval Date:	Jul 1, 2016	TE:	AP	RLD:	No

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