Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 063116
Company: HOSPIRA

Products on ANDA 063116

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRAMYCIN SULFATE (PHARMACY BULK)	TOBRAMYCIN SULFATE	EQ 40MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063116

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/18/1992	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
12/08/2011	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063116s010lbl.pdf
10/04/2004	SUPPL-7	Labeling		Label is not available on this site.
10/25/2002	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
02/16/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/03/1996	SUPPL-3	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
08/02/1994	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 063116

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2011	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/063116s010lbl.pdf