Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 205257
Company: MYLAN

• REMS

Products on ANDA 205257

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205257

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/2015	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
12/15/2023	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/10/2021	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/04/2021	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-6	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/24/2018	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/29/2017	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/21/2017	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.