An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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

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	Yes
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
12/23/2025	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
09/03/2025	SUPPL-21	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208708Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208708Orig1s021ltr.pdf
10/31/2024	SUPPL-18	REMS - MODIFIED - D-N-A		Label is not available on this site.
07/01/2025	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
04/04/2024	SUPPL-16	Manufacturing (CMC)-New Strength	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/208708Orig1s016.pdf
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.

Labels for ANDA 208708

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2025	SUPPL-21	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208708Orig1s021lbl.pdf
09/03/2025	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208708Orig1s021lbl.pdf

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	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

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	075968	GRAVITI PHARMS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AB	208708	RUBICON RESEARCH

Top