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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208833
Company: AMNEAL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CELECOXIB CELECOXIB 50MG CAPSULE;ORAL Prescription BX No No
CELECOXIB CELECOXIB 100MG CAPSULE;ORAL Prescription BX No No
CELECOXIB CELECOXIB 200MG CAPSULE;ORAL Prescription BX No No
CELECOXIB CELECOXIB 400MG CAPSULE;ORAL Prescription BX 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
05/31/2018 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
01/10/2023 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

01/10/2023 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/01/2019 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/02/2019 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

CELECOXIB

There are no Therapeutic Equivalents.

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