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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063081
Company: HOSPIRA

Products on ANDA 063081

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	TOBRAMYCIN SULFATE	EQ 80MG BASE/100ML	INJECTABLE;INJECTION	Discontinued	None	No	No
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	TOBRAMYCIN SULFATE	EQ 1.2MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	TOBRAMYCIN SULFATE	EQ 1.6MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063081

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/1990	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-37	Labeling-Package Insert		Label is not available on this site.
09/18/2015	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
12/08/2011	SUPPL-30	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063081s030lbl.pdf
10/21/2004	SUPPL-18	Labeling		Label is not available on this site.
11/01/2002	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/16/1999	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
12/01/1998	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
05/02/1997	SUPPL-14	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/02/1997	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/12/1996	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/03/1996	SUPPL-10	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
03/11/1994	SUPPL-9	Labeling		Label is not available on this site.
05/05/1994	SUPPL-8	Labeling		Label is not available on this site.
01/14/1994	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/02/1993	SUPPL-6	Labeling		Label is not available on this site.
06/02/1993	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/10/1992	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/10/1992	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/18/1991	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for ANDA 063081

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2011	SUPPL-30	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063081s030lbl.pdf

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