Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091607
Company: SUN PHARM
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 Yes
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
12/30/2011 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091607Orig1s000Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2011/091607Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/11/2019 SUPPL-19 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/21/2018 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-14 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/29/2017 SUPPL-12 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/29/2017 SUPPL-11 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

08/21/2017 SUPPL-10 Labeling

Label is not available on this site.

12/16/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-7 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 200491 ANCHEN PHARMS
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 200491 ANCHEN PHARMS
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 200491 ANCHEN PHARMS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB2 091607 SUN PHARM

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