Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072237
Company: COSETTE

Products on ANDA 072237

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACEPHEN	ACETAMINOPHEN	650MG	SUPPOSITORY;RECTAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 072237

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/27/1992	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
11/10/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/10/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/24/2013	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
08/19/2010	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/19/2010	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/29/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/04/1996	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
07/10/1992	SUPPL-1	Labeling		Label is not available on this site.