Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202402
Company: X-GEN PHARMS INC
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
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
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

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 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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