Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075936
Company: FRESENIUS KABI USA

Products on ANDA 075936

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075936

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/2001/75936taf.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/08/2007	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075936

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