Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040362
Company: JUBILANT CADISTA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription AB No No
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription AB No No
PREDNISONE PREDNISONE 20MG 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
08/29/2001 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/40362ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/29/2005 SUPPL-4 Labeling

Label is not available on this site.

06/29/2005 SUPPL-3

Label is not available on this site.

05/11/2004 SUPPL-2 Labeling

Label is not available on this site.

PREDNISONE

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 210525 GENEYORK PHARMS
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No 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 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; 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 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 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; 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 210525 GENEYORK PHARMS
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No 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 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

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