Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 205570
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARGATROBAN IN SODIUM CHLORIDE ARGATROBAN 125MG/125ML (1MG/ML) INJECTABLE;IV (INFUSION) 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
05/22/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205570Orig1s000ltr.pdf

ARGATROBAN IN SODIUM CHLORIDE

INJECTABLE;IV (INFUSION); 125MG/125ML (1MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARGATROBAN IN SODIUM CHLORIDE ARGATROBAN 125MG/125ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription No AP 205570 GLAND PHARMA LTD
ARGATROBAN IN SODIUM CHLORIDE ARGATROBAN 125MG/125ML (1MG/ML) INJECTABLE;IV (INFUSION) Prescription Yes AP 022485 SANDOZ

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