Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018878
Company: RECORDATI RARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOCIN INDOMETHACIN SODIUM EQ 1MG BASE/VIAL INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/30/1985 ORIG-1 Approval Type 3 - New Dosage Form PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/19/2010 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018878s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/018878s027ltr.pdf
01/12/2007 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018878s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018878s024ltr.pdf
02/01/2006 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018878s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018878s023ltr.pdf
11/08/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/2003 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18878slr018,019ltr.pdf
05/06/2003 SUPPL-18 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18878slr018,019ltr.pdf
02/12/2001 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

11/16/2000 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/2000 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/15/1998 SUPPL-14 Labeling

Label is not available on this site.

10/14/1997 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

09/13/1994 SUPPL-11 Labeling

Label is not available on this site.

09/21/1994 SUPPL-10 Labeling

Label is not available on this site.

06/08/1988 SUPPL-5 Labeling

Label is not available on this site.

06/20/1985 SUPPL-2 Labeling

Label is not available on this site.

10/31/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/19/2010 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/018878s027lbl.pdf
01/12/2007 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018878s024lbl.pdf
02/01/2006 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018878s023lbl.pdf

INDOCIN

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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