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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078857
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Discontinued None No No
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Discontinued None No No
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Discontinued None No No
CELECOXIB CELECOXIB 400MG CAPSULE;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
02/11/2015 ORIG-2 Approval

Label is not available on this site.

05/30/2014 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/078857Orig2s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/09/2022 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/09/2019 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

04/02/2019 SUPPL-5 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/16/2016 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/10/2015 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

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