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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040581
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 2.5MG 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
12/21/2004 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/16/2008 SUPPL-2 Labeling

Label is not available on this site.

PREDNISONE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription No AB 215672 AUROBINDO PHARMA LTD
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription Yes AB 087801 HIKMA
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription No AB 040362 JUBILANT CADISTA
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription No AB 211575 NOVITIUM PHARMA
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription No AB 209727 STRIDES PHARMA
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription No AB 040581 VINTAGE PHARMS
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