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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206965
Company: BAXTER HLTHCARE CORP

Products on ANDA 206965

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206965

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/01/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/10/2023	SUPPL-7	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
01/17/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/17/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206965

TOBRAMYCIN SULFATE

INJECTABLE;INJECTION; EQ 40MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	206965	BAXTER HLTHCARE CORP
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	065122	FRESENIUS KABI USA
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	209621	GLAND PHARMA LTD
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	063117	HIKMA
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	063111	HOSPIRA
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	065407	MYLAN LABS LTD
TOBRAMYCIN SULFATE (PHARMACY BULK)	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	065120	FRESENIUS KABI USA
TOBRAMYCIN SULFATE (PHARMACY BULK)	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	209346	GLAND PHARMA LTD

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