Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203049
Company: HIKMA PHARM CO LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription AP No No
ARGATROBAN ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE;INJECTION Prescription None 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
01/05/2012 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203049s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203049s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203049_argatroban_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203049Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/26/2016 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203049Orig1s005ltr.pdf
09/30/2016 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203049Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/203049Orig1s004.pdf
10/16/2014 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/13/2013 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/30/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s004lbl.pdf
05/26/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203049s005lbl.pdf
01/05/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203049s000lbl.pdf

ARGATROBAN

INJECTABLE;INJECTION; 250MG/2.5ML (100MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription No AP 201811 FRESENIUS KABI USA
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription No AP 203049 HIKMA PHARM CO LTD
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription No AP 204120 HOSPIRA INC
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription No AP 202626 MYLAN INSTITUTIONAL
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020883 NOVARTIS PHARMS CORP
ARGATROBAN ARGATROBAN 250MG/2.5ML (100MG/ML) INJECTABLE;INJECTION Prescription No AP 091665 PAR STERILE PRODUCTS

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