Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207809
Company: ALVOGEN MALTA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MELPHALAN MELPHALAN 2MG 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
03/22/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207809Orig1s000ltr.pdf

MELPHALAN

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ALKERAN MELPHALAN 2MG TABLET;ORAL Prescription Yes AB 014691 APOTEX INC
MELPHALAN MELPHALAN 2MG TABLET;ORAL Prescription No AB 207809 ALVOGEN MALTA

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