Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089247
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription AB No No
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription AB No No
PREDNISONE PREDNISONE 10MG 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
12/04/1985 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
12/20/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/2001 SUPPL-17 Labeling

Label is not available on this site.

05/20/2002 SUPPL-16 Labeling

Label is not available on this site.

06/14/2002 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

08/10/2000 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/06/1994 SUPPL-7 Labeling

Label is not available on this site.

01/06/1994 SUPPL-6 Labeling

Label is not available on this site.

01/12/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/08/1990 SUPPL-4 Labeling

Label is not available on this site.

02/01/1990 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/06/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/06/1988 SUPPL-1 Labeling

Label is not available on this site.

PREDNISONE

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 040362 JUBILANT CADISTA
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 083677 MYLAN
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
PREDNISONE PREDNISONE 20MG TABLET;ORAL Prescription No AB 087342 WEST-WARD PHARMS INT

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 040362 JUBILANT CADISTA
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 080292 MYLAN
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
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription No AB 080352 WEST-WARD PHARMS INT

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 040362 JUBILANT CADISTA
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 088832 MYLAN
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
PREDNISONE PREDNISONE 10MG TABLET;ORAL Prescription No AB 084122 WEST-WARD PHARMS INT

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