Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074616
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMRINONE LACTATE INAMRINONE LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/03/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74616ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/07/2001 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

07/24/2000 SUPPL-1 Labeling

Label is not available on this site.

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