Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 081249
Company: FOSUN PHARMA

• REMS

Products on ANDA 081249

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 081249

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/1992	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
12/15/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
10/07/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-11	REMS - PROPOSAL - D-N-A		Label is not available on this site.
09/20/2018	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
08/29/2017	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/29/2017	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/21/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/23/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
08/11/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
01/24/1994	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.