Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201811
Company: FRESENIUS KABI USA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/23/2015 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/2015/201811s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201811Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201811Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/201811Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/25/2016 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201811s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201811Orig1s003ltr.pdf
12/11/2015 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/25/2016 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201811s003lbl.pdf
03/23/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201811s000lbl.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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