Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075513
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMRINONE LACTATE INAMRINONE LACTATE EQ 5MG BASE/ML INJECTABLE;INJECTION Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/09/2000 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
04/03/2001 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

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