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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213301
Company: UNICHEM
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
01/12/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/14/2021 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

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