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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091609
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 No No
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 No No
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription AB2 No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/27/2012 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
09/10/2021 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/04/2021 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/11/2019 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.

08/29/2017 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/21/2017 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

TRAMADOL HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB2

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 AB2 091609 ACTAVIS ELIZABETH
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 091607 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 200MG
TE Code = AB2

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 AB2 091609 ACTAVIS ELIZABETH
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 091607 SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 300MG
TE Code = AB2

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 AB2 091609 ACTAVIS ELIZABETH
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 091607 SUN PHARM
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