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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075660
Company: HIKMA

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
MILRINONE LACTATE MILRINONE LACTATE EQ 20MG /20ML (1MG/ML) Injectable; Injection Prescription AP No No
MILRINONE LACTATE MILRINONE LACTATE EQ 50MG /50ML (1MG/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 Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75660_Milrinone%20Lactate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75660_Milrinone%20Lactate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075660_milrinone-lactate_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/17/2007 SUPPL-5 Labeling

Label is not available on this site.

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/2002/75660_Milrinone%20Lactate_Prntlbl.pdf

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 075530 HIKMA
MILRINONE LACTATE MILRINONE LACTATE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075660 HIKMA
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
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 216373 SHANDONG

Injectable; Injection; EQ 20MG /20ML (1MG/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 20MG /20ML (1MG/ML) Injectable; Injection Prescription No AP 075660 HIKMA

Injectable; Injection; EQ 50MG /50ML (1MG/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 50MG /50ML (1MG/ML) Injectable; Injection Prescription No AP 075660 HIKMA
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