An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021903
Company: RECORDATI RARE

Products on NDA 021903

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021903

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
10/25/2023	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021903s014lbl.pdf
03/26/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021903s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021903Orig1s012ltr.pdf
08/14/2019	SUPPL-11	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021903Orig1s011ltr.pdf
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

Labels for NDA 021903

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2023	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021903s014lbl.pdf
03/26/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021903s012lbl.pdf
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

Therapeutic Equivalents for NDA 021903

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	XGEN PHARMS
NEOPROFEN	IBUPROFEN LYSINE	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	021903	RECORDATI RARE

Top