Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091665
Company: PAR STERILE PRODUCTS
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
06/30/2014 ORIG-1 Approval

Label is not available on this site.

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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