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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211575
Company: NOVITIUM PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription AB No No
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription AB No No
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription AB No No
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription AB No No
PREDNISONE PREDNISONE 50MG 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
11/15/2019 ORIG-1 Approval STANDARD

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 No AB 211495 GENEYORK PHARMS
PREDNISONE PREDNISONE 2.5MG TABLET;ORAL Prescription No AB 087801 HIKMA
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

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 213385 AMNEAL
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 215672 AUROBINDO PHARMA LTD
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 211495 GENEYORK PHARMS
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 080352 HIKMA
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 040362 JUBILANT CADISTA
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 080292 MYLAN
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 211575 NOVITIUM PHARMA
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 209727 STRIDES PHARMA
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 089247 SUN PHARM INDUSTRIES
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 040256 VINTAGE PHARMS
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 080356 WATSON LABS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 213386 AMNEAL
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 215672 AUROBINDO PHARMA LTD
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 210525 GENEYORK PHARMS
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription Yes AB 084122 HIKMA
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 040362 JUBILANT CADISTA
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 088832 MYLAN
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 211575 NOVITIUM PHARMA
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 208412 STRIDES PHARMA
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 089247 SUN PHARM INDUSTRIES
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 040256 VINTAGE PHARMS
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 085162 WATSON LABS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 213386 AMNEAL
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 215672 AUROBINDO PHARMA LTD
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 210525 GENEYORK PHARMS
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription Yes AB 087342 HIKMA
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 040362 JUBILANT CADISTA
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 083677 MYLAN
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 211575 NOVITIUM PHARMA
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 208412 STRIDES PHARMA
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 089247 SUN PHARM INDUSTRIES
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 040392 VINTAGE PHARMS
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 085161 WATSON LABS

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PREDNISONE PREDNISONE 50MG TABLET;ORAL Prescription No AB 215672 AUROBINDO PHARMA LTD
PREDNISONE PREDNISONE 50MG TABLET;ORAL Prescription No AB 210525 GENEYORK PHARMS
PREDNISONE PREDNISONE 50MG TABLET;ORAL Prescription No AB 084283 HIKMA
PREDNISONE PREDNISONE 50MG TABLET;ORAL Prescription No AB 211575 NOVITIUM PHARMA
PREDNISONE PREDNISONE 50MG TABLET;ORAL Prescription No AB 208412 STRIDES PHARMA
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