Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208708
Company: RUBICON
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
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG 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
06/28/2019 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208708Orig1s000ltr.pdf

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 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

TABLET;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE 100MG TABLET;ORAL Prescription No AB 208708 RUBICON

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