An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 063111
Company: HOSPIRA

Products on ANDA 063111

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 063111

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/1991	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-22	Labeling-Package Insert		Label is not available on this site.
09/21/2015	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
12/08/2011	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063111s014lbl.pdf
04/07/2005	SUPPL-11	Labeling		Label is not available on this site.
04/07/2005	SUPPL-10	Labeling		Label is not available on this site.
04/27/2004	SUPPL-9	Labeling		Label is not available on this site.
10/25/2002	SUPPL-8	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/16/1999	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
10/03/1996	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
12/10/1993	SUPPL-3	Labeling		Label is not available on this site.
04/02/1993	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
10/30/1991	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 063111

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2011	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063111s014lbl.pdf

Therapeutic Equivalents for ANDA 063111

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

Top