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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065122
Company: FRESENIUS KABI USA

Products on ANDA 065122

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065122

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2002	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
02/10/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/01/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
02/01/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
02/01/2023	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
01/29/2014	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065122s008lbl.pdf
09/26/2005	SUPPL-4	Labeling		Label is not available on this site.
04/01/2004	SUPPL-3	Labeling		Label is not available on this site.

Labels for ANDA 065122

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/29/2014	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/065122s008lbl.pdf

Therapeutic Equivalents for ANDA 065122

TOBRAMYCIN SULFATE

INJECTABLE;INJECTION; EQ 10MG 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 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	065122	FRESENIUS KABI USA
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	209621	GLAND

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
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

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