Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 063112
Company: HOSPIRA

Products on ANDA 063112

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TOBRAMYCIN SULFATE	TOBRAMYCIN SULFATE	EQ 10MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 063112

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.
09/18/2015	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
01/12/2012	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063112Orig1s015lbl.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.
11/15/1991	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 063112

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/12/2012	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/063112Orig1s015lbl.pdf