Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208833
Company: AMNEAL PHARMS

Products on ANDA 208833

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208833

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-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
01/10/2023	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/01/2019	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		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.

Therapeutic Equivalents for ANDA 208833

CELECOXIB

There are no Therapeutic Equivalents.