Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075830
Company: HOSPIRA

Products on ANDA 075830

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MILRINONE LACTATE	MILRINONE LACTATE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075830

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/28/2002	ORIG-1	Approval			Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75830_Milrinone%20Lactate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75830tadf.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75830_Milrinone%20Lactate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075830_milrinone-lactate_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/02/2004	SUPPL-2	Labeling		Label is not available on this site.
12/20/2002	SUPPL-1	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.

Labels for ANDA 075830

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75830_Milrinone%20Lactate_Prntlbl.pdf