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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200503
Company: LUPIN LTD

REMS

Products on ANDA 200503

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	Yes
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 200503

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/29/2011	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
12/23/2025	SUPPL-21	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/31/2024	SUPPL-18	REMS - MODIFIED - D-N-A		Label is not available on this site.
10/21/2025	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/10/2021	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/04/2021	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/09/2019	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/21/2018	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-7	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/24/2018	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/29/2017	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/15/2015	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200503

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	209404	MACLEODS PHARMS LTD

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	209404	MACLEODS PHARMS LTD

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	209404	MACLEODS PHARMS LTD

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