Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204310
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG 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
08/28/2015 ORIG-1 Approval

Label is not available on this site.

RALOXIFENE HYDROCHLORIDE

TABLET;ORAL; 60MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
EVISTA RALOXIFENE HYDROCHLORIDE 60MG TABLET;ORAL Prescription Yes AB 020815 LILLY
RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 208206 AMNEAL PHARMS
RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 204310 AUROBINDO PHARMA LTD
RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 204491 GLENMARK PHARMS LTD
RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 090842 INVAGEN PHARMS
RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 206384 SCIEGEN PHARMS INC
RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 078193 TEVA PHARMS USA
RALOXIFENE HYDROCHLORIDE RALOXIFENE HYDROCHLORIDE 60MG TABLET;ORAL Prescription No AB 200825 WATSON LABS INC

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