Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075981
Company: APOTEX

• REMS

Products on ANDA 075981

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075981

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2002	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-29	Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-28	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/15/2025	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
10/19/2023	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
10/19/2023	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
10/19/2023	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
10/19/2023	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
10/19/2023	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/19/2023	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-18	REMS - PROPOSAL - D-N-A		Label is not available on this site.
10/19/2023	SUPPL-17	Labeling-Patient Package Insert		Label is not available on this site.
10/19/2023	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/13/2015	SUPPL-13	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/27/2008	SUPPL-7	Labeling		Label is not available on this site.
11/03/2003	SUPPL-2	Labeling		Label is not available on this site.