Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021903
Company: RECORDATI RARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEOPROFEN IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE;INTRAVENOUS 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
04/13/2006 ORIG-1 Approval Type 2 - New Active Ingredient PRIORITY; Orphan Label (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021903lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/21-903s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/16/2017 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021903s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021903Orig1s010ltr.pdf
01/13/2016 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021903s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021903Orig1s009ltr.pdf
12/03/2013 SUPPL-8 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021903s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021903Orig1s008ltr.pdf
02/28/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

12/22/2009 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021903s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021903s004ltr.pdf
09/12/2008 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021903s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/16/2017 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021903s010lbl.pdf
01/13/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021903s009lbl.pdf
12/03/2013 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021903s008lbl.pdf
12/22/2009 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021903s004lbl.pdf
04/13/2006 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021903lbl.pdf

NEOPROFEN

INJECTABLE;INTRAVENOUS; EQ 20MG BASE/2ML (EQ 10MG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
IBUPROFEN LYSINE IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription No AP 202402 X-GEN PHARMS INC
NEOPROFEN IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE;INTRAVENOUS Prescription Yes AP 021903 RECORDATI RARE

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