Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203494
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription AB 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
03/31/2014 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-8 REMS - PROPOSAL - D-N-A

Label is not available on this site.

10/26/2015 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

TRAMADOL HYDROCHLORIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 202075 ACI HEALTHCARE LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 076003 AMNEAL PHARMS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075981 APOTEX
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 203494 AUROBINDO PHARMA LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 091498 CSPC OUYI PHARM CO
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 201973 IPCA LABS LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 205702 MACLEODS PHARMS LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075986 MYLAN
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075982 PLIVA
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 206706 POLYGEN PHARMS
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 208708 RUBICON
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075983 SPECGX LLC
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075964 SUN PHARM INDS INC
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 076100 SUN PHARM INDUSTRIES
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 075977 TEVA
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 211825 UNICHEM LABS LTD
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription No AB 090404 ZYDUS PHARMS USA INC
ULTRAM TRAMADOL HYDROCHLORIDE 50MG TABLET;ORAL Prescription Yes AB 020281 JANSSEN PHARMS

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