Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075530
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MILRINONE LACTATE MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription AP 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
05/28/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75530ta.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/10/2007 SUPPL-1 Labeling

Label is not available on this site.

MILRINONE LACTATE

INJECTABLE;INJECTION; EQ 1MG BASE/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MILRINONE LACTATE MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 214380 CAPLIN
MILRINONE LACTATE MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075936 FRESENIUS KABI USA
MILRINONE LACTATE MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 077966 HIKMA FARMACEUTICA
MILRINONE LACTATE MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 203280 HOSPIRA INC
MILRINONE LACTATE MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 211671 MEITHEAL
MILRINONE LACTATE MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075530 WEST-WARD PHARMS INT
MILRINONE LACTATE MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075660 WEST-WARD PHARMS INT

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