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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201384
Company: SUN PHARM

REMS

Products on ANDA 201384

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201384

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/2011	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
12/15/2023	SUPPL-29	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-28	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-26	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/10/2021	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-21	Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/11/2019	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/21/2018	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-12	REMS - PROPOSAL - D-N-A		Label is not available on this site.
09/09/2019	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/29/2017	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/21/2017	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201384

TRAMADOL HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	200503	LUPIN LTD
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	201384	SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	200503	LUPIN LTD
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	200MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	201384	SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	200503	LUPIN LTD
TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	300MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB1	201384	SUN PHARM

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