Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 089998
Company: CHARTWELL

• Safety Labeling Change Order Letter

• REMS

Products on ANDA 089998

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 089998

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/28/1994	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-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/09/2019	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-21	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/29/2017	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/16/2016	SUPPL-18	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/03/2015	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
08/29/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
04/12/2001	SUPPL-11	Manufacturing (CMC)-Facility		Label is not available on this site.
03/21/2000	SUPPL-10	Manufacturing (CMC)-Facility		Label is not available on this site.
11/17/2000	SUPPL-9	Labeling		Label is not available on this site.
11/17/2000	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
11/17/2000	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
11/17/2000	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
11/17/2000	SUPPL-5	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/21/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/08/1997	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/28/1996	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.