Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 064106
Company: HOSPIRA

Products on ANDA 064106

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MITOMYCIN	MITOMYCIN	20MG/VIAL	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064106

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/1995	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
07/30/2001	SUPPL-11	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/14/2001	SUPPL-10	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
10/11/2000	SUPPL-8	Labeling		Label is not available on this site.
07/12/2000	SUPPL-7	Manufacturing (CMC)-Control		Label is not available on this site.
08/08/2000	SUPPL-6	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/15/2000	SUPPL-5	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
05/12/2000	SUPPL-4	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.
06/18/1999	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.