Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202075
Company: ACI

• REMS

Products on ANDA 202075

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 202075

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/28/2011	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2023	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
06/28/2022	SUPPL-4	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/14/2019	SUPPL-2	REMS - PROPOSAL - D-N-A		Label is not available on this site.

Therapeutic Equivalents for ANDA 202075

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	202075	ACI
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	076003	AMNEAL PHARMS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	075981	APOTEX
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	201973	IPCA LABS LTD
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	206706	MERRO PHARM USA
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	208708	RUBICON
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
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AB	090404	ZYDUS PHARMS USA INC