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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215671
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 1MG 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
11/16/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

PREDNISONE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 1MG TABLET;ORAL Prescription No AB 213385 AMNEAL
PREDNISONE PREDNISONE 1MG TABLET;ORAL Prescription No AB 215671 AUROBINDO PHARMA LTD
PREDNISONE PREDNISONE 1MG TABLET;ORAL Prescription No AB 211496 GENEYORK PHARMS
PREDNISONE PREDNISONE 1MG TABLET;ORAL Prescription Yes AB 087800 HIKMA
PREDNISONE PREDNISONE 1MG TABLET;ORAL Prescription No AB 040611 JUBILANT CADISTA
PREDNISONE PREDNISONE 1MG TABLET;ORAL Prescription No AB 215246 NOVITIUM PHARMA
PREDNISONE PREDNISONE 1MG TABLET;ORAL Prescription No AB 210785 STRIDES PHARMA
PREDNISONE PREDNISONE 1MG TABLET;ORAL Prescription No AB 040584 VINTAGE PHARMS
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