Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205685
Company: XELLIA PHARMS APS

Products on ANDA 205685

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205685

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/16/2014	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-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205685

TOBRAMYCIN SULFATE

INJECTABLE;INJECTION; EQ 1.2GM BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	217519	EUGIA PHARMA
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	050789	FRESENIUS KABI USA
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	211189	GLAND PHARMA LTD
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	217029	HAINAN POLY
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	205685	XELLIA PHARMS APS
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 1.2GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	065013	XGEN PHARMS