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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215503
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIRAGLUTIDE LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION;SUBCUTANEOUS Prescription AP1 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
12/23/2024 ORIG-1 Approval STANDARD Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215503Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/215503Orig1s000edt.pdf

LIRAGLUTIDE

SOLUTION;SUBCUTANEOUS; 18MG/3ML (6MG/ML)
TE Code = AP1

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LIRAGLUTIDE LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION;SUBCUTANEOUS Prescription No AP1 215245 BIOCON PHARMA
LIRAGLUTIDE LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION;SUBCUTANEOUS Prescription No AP1 212552 FRESENIUS KABI USA
LIRAGLUTIDE LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION;SUBCUTANEOUS Prescription No AP1 215503 HIKMA
LIRAGLUTIDE LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION;SUBCUTANEOUS Prescription No AP1 215421 LUPIN LTD
LIRAGLUTIDE LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION;SUBCUTANEOUS Prescription No AP1 218115 NANJING KING FRIEND
LIRAGLUTIDE LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION;SUBCUTANEOUS Prescription No AP1 217590 ORBICULAR
VICTOZA LIRAGLUTIDE 18MG/3ML (6MG/ML) SOLUTION;SUBCUTANEOUS Prescription Yes AP1 022341 NOVO NORDISK INC
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