Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072267
Company: XSPIRE PHARMA

Products on ANDA 072267

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FENOPROFEN CALCIUM	FENOPROFEN CALCIUM	EQ 600MG BASE	TABLET;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072267

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/1988	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/28/2021	SUPPL-25	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/09/2016	SUPPL-23	Labeling-Medication Guide		Label is not available on this site.
04/24/2015	SUPPL-22	Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
12/20/2007	SUPPL-19	Labeling		Label is not available on this site.
05/16/2006	SUPPL-16	Labeling		Label is not available on this site.
03/13/2006	SUPPL-15	Labeling		Label is not available on this site.
02/05/1998	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
06/26/1998	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
03/04/1997	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/09/1991	SUPPL-9	Labeling		Label is not available on this site.
10/31/1991	SUPPL-8	Labeling		Label is not available on this site.
10/31/1991	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/31/1990	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
08/11/1988	SUPPL-3	Labeling		Label is not available on this site.