Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202402
Company: XGEN PHARMS

Products on ANDA 202402

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBUPROFEN LYSINE	IBUPROFEN LYSINE	EQ 20MG BASE/2ML (EQ 10MG BASE/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202402

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2016	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202402Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202402Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/03/2024	SUPPL-5	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 202402

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/30/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202402Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 202402

IBUPROFEN LYSINE

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