Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206885
Company: MACLEODS PHARMS LTD
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/02/2017 ORIG-1 Approval STANDARD

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-10 REMS - PROPOSAL - D-N-A

Label is not available on this site.

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 078778 APOTEX
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription No AB 207152 AUROBINDO PHARMA LTD
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription No AB 206885 MACLEODS PHARMS LTD
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 MYLAN
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription No AB 076475 PAR PHARM
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription No AB 077184 SUN PHARM INDS INC
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription No AB 090460 ZYDUS PHARMS USA INC
ULTRACET ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE 325MG;37.5MG TABLET;ORAL Prescription Yes AB 021123 JANSSEN PHARMS

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