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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210013
Company: MICRO LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APIXABAN APIXABAN 2.5MG TABLET;ORAL Discontinued None No No
APIXABAN APIXABAN 5MG TABLET;ORAL Discontinued None 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
12/23/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210013Orig1s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/20/2022 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

05/20/2022 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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