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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201952
Company: MICRO LABS LTD INDIA

REMS

Products on ANDA 201952

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201952

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2012	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
12/22/2025	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/31/2024	SUPPL-16	REMS - MODIFIED - D-N-A		Label is not available on this site.
12/12/2025	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
12/15/2023	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
08/03/2022	SUPPL-13	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/03/2022	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/03/2022	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
08/03/2022	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
09/18/2018	SUPPL-9	REMS - PROPOSAL - D-N-A		Label is not available on this site.
08/03/2022	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/03/2022	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
03/23/2017	SUPPL-6	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/01/2014	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201952

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

TABLET;ORAL; 325MG;37.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET;ORAL	Prescription	No	AB	202076	ALKEM LABS LTD
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET;ORAL	Prescription	No	AB	090485	AMNEAL PHARMS
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET;ORAL	Prescription	No	AB	207152	AUROBINDO PHARMA
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET;ORAL	Prescription	No	AB	201952	MICRO LABS LTD INDIA
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET;ORAL	Prescription	No	AB	077858	RISING
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE	325MG;37.5MG	TABLET;ORAL	Prescription	No	AB	090460	ZYDUS PHARMS USA INC

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