Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078713
Company: WEST-WARD PHARMS INT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN SODIUM INDOMETHACIN SODIUM EQ 1MG BASE/VIAL 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
07/16/2008 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078713s000ltr.pdf

INDOMETHACIN SODIUM

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDOCIN INDOMETHACIN SODIUM EQ 1MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 018878 RECORDATI RARE
INDOMETHACIN SODIUM INDOMETHACIN SODIUM EQ 1MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 204118 HOSPIRA INC
INDOMETHACIN SODIUM INDOMETHACIN SODIUM EQ 1MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 206561 NAVINTA LLC
INDOMETHACIN SODIUM INDOMETHACIN SODIUM EQ 1MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 078713 WEST-WARD PHARMS INT

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