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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208708
Company: RUBICON

REMS

Products on ANDA 208708

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
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	AB	No	No
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	None	No	No
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	75MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208708

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208708Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/27/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
12/15/2023	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/06/2023	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
10/06/2023	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
01/13/2021	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/13/2021	SUPPL-1	Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 208708

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

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	208708	RUBICON

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