Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213301
Company: UNICHEM

Products on ANDA 213301

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213301

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.