Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091238
Company: CHARTWELL MOLECULAR

• REMS

Products on ANDA 091238

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN AND CODEINE PHOSPHATE	ACETAMINOPHEN; CODEINE PHOSPHATE	120MG/5ML;12MG/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091238

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/10/2011	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
12/22/2025	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/05/2025	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/07/2019	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/21/2018	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/18/2018	SUPPL-15	REMS - PROPOSAL - D-N-A		Label is not available on this site.
02/21/2018	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
02/21/2018	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
08/29/2017	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/29/2017	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
12/16/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
10/18/2013	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/27/2013	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
06/27/2013	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.