Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075977
Company: TEVA

• REMS

Products on ANDA 075977

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 075977

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/19/2002	ORIG-1	Approval			Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75977lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75977ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/075977_ORIGINAL APPROVAL_PACKAGE.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/18/2023	SUPPL-32	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/18/2023	SUPPL-31	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/22/2024	SUPPL-29	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/07/2023	SUPPL-28	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/07/2023	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/07/2023	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
12/07/2023	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/07/2023	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-17	REMS - PROPOSAL - D-N-A		Label is not available on this site.
12/07/2023	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/07/2023	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/09/2015	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/22/2010	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
04/08/2005	SUPPL-3	Labeling		Label is not available on this site.
10/30/2002	SUPPL-1	Labeling		Label is not available on this site.

Labels for ANDA 075977

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/19/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/75977lbl.pdf

Therapeutic Equivalents for ANDA 075977

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