Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206885
Company: MACLEODS PHARMS LTD

• REMS

Products on ANDA 206885

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206885

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/02/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/29/2025	SUPPL-32	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/31/2024	SUPPL-29	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/15/2025	SUPPL-28	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-27	Labeling-Package Insert, Labeling-Medication Guide		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.
12/08/2023	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
06/07/2023	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
12/08/2023	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/08/2023	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/08/2023	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/08/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-10	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/08/2023	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.