Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204209
Company: PHARMOBEDIENT

• REMS

Products on ANDA 204209

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	325MG;30MG;16MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204209

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/30/2016	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204209Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/14/2025	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-12	Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
10/07/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/20/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-7	REMS - PROPOSAL - D-N-A		Label is not available on this site.
11/09/2018	SUPPL-6	Labeling-Proprietary Name Change, Labeling-Container/Carton Labels		Label is not available on this site.
08/29/2017	SUPPL-5	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.