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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210180
Company: ACCORD HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APIXABAN APIXABAN 2.5MG TABLET;ORAL Prescription AB No No
APIXABAN APIXABAN 5MG TABLET;ORAL Prescription AB 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
07/28/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

APIXABAN

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APIXABAN APIXABAN 2.5MG TABLET;ORAL Prescription No AB 210180 ACCORD HLTHCARE
APIXABAN APIXABAN 2.5MG TABLET;ORAL Prescription No AB 209898 INDOCO
ELIQUIS APIXABAN 2.5MG TABLET;ORAL Prescription Yes AB 202155 BRISTOL MYERS SQUIBB

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
APIXABAN APIXABAN 5MG TABLET;ORAL Prescription No AB 210180 ACCORD HLTHCARE
APIXABAN APIXABAN 5MG TABLET;ORAL Prescription No AB 209898 INDOCO
ELIQUIS APIXABAN 5MG TABLET;ORAL Prescription Yes AB 202155 BRISTOL MYERS SQUIBB
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