Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211825
Company: UNICHEM

• REMS

Products on ANDA 211825

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211825

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/2019	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
02/13/2026	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/13/2026	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/31/2024	SUPPL-15	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/15/2023	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/15/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
11/30/2023	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/30/2023	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/30/2023	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/11/2020	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 211825

TRAMADOL HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	076003	AMNEAL PHARMS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	203494	AUROBINDO PHARMA LTD
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	091498	CSPC OUYI PHARM CO
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	075968	GRAVITI PHARMS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	208708	RUBICON RESEARCH
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	090404	SENORES PHARMS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	202075	STRIDES PHARMA
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	075964	SUN PHARM INDS INC
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	075977	TEVA
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	211825	UNICHEM