Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040223
Company: DURAMED PHARMS BARR

• Safety Labeling Change Order Letter

Products on ANDA 040223

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;15MG	TABLET;ORAL	Discontinued	None	No	No
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;30MG	TABLET;ORAL	Discontinued	None	No	No
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	300MG;60MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040223

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/1997	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
10/21/2013	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
10/21/2013	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
02/14/2008	SUPPL-23	Labeling		Label is not available on this site.
10/25/2007	SUPPL-22	Labeling		Label is not available on this site.
12/09/2002	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
12/09/2002	SUPPL-13	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
12/09/2002	SUPPL-12	Manufacturing (CMC)-Facility		Label is not available on this site.
04/09/2002	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
04/09/2002	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
04/09/2002	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/09/2002	SUPPL-8	Manufacturing (CMC)-Facility		Label is not available on this site.
06/05/2000	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/05/2000	SUPPL-6	Manufacturing (CMC)-Formulation		Label is not available on this site.
06/05/2000	SUPPL-5	Labeling		Label is not available on this site.
06/05/2000	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
06/05/2000	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/05/2000	SUPPL-2	Manufacturing (CMC)-Manufacturing Process		Label is not available on this site.
05/20/1999	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.