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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214235
Company: CAPLIN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARGATROBAN ARGATROBAN 50MG/50ML (1MG/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
01/21/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214235Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/17/2025 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

ARGATROBAN

INJECTABLE;INJECTION; 50MG/50ML (1MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ARGATROBAN ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE;INJECTION Prescription No AP 214235 CAPLIN
ARGATROBAN ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE;INJECTION Prescription No AP 217848 GLAND
ARGATROBAN ARGATROBAN 50MG/50ML (1MG/ML) INJECTABLE;INJECTION Prescription Yes AP 203049 HIKMA PHARM CO LTD
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