Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075660
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
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 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

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 WEST-WARD PHARMS INT

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 WEST-WARD PHARMS INT

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English