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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065013
Company: XGEN PHARMS

Products on ANDA 065013

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065013

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2001	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/29/2023	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
02/10/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
08/16/2013	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/09/2012	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/07/2013	SUPPL-10	Labeling		Label is not available on this site.
10/31/2012	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/18/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
01/17/2012	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065013s007lbl.pdf
12/09/2002	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 065013

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2012	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/065013s007lbl.pdf

Therapeutic Equivalents for ANDA 065013

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

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