Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078783
Company: PAR PHARM INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/13/2009 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078783s000(2)ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078783s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/09/2019 SUPPL-10 Labeling-Medication Guide, Labeling-Container/Carton Labels

Label is not available on this site.

09/21/2018 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-8 REMS - PROPOSAL - D-N-A

Label is not available on this site.

08/29/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

08/21/2017 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

08/21/2017 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

09/20/2011 SUPPL-1 Efficacy-New Dosing Regimen

Label is not available on this site.

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 205257 MYLAN
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 078783 PAR PHARM INC
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 205257 MYLAN
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 200MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 078783 PAR PHARM INC
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 205257 MYLAN
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 078783 PAR PHARM INC
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 300MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB1 201384 SUN PHARM

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