Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 080352
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREDNISONE PREDNISONE 5MG TABLET;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/21/1972 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
11/24/2008 SUPPL-63 Labeling

Label is not available on this site.

03/11/1997 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

06/09/1997 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

06/09/1997 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

07/13/1995 SUPPL-49 Labeling

Label is not available on this site.

06/09/1997 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

06/09/1997 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

02/22/1995 SUPPL-46 Labeling

Label is not available on this site.

10/07/1994 SUPPL-45 Labeling

Label is not available on this site.

03/30/1994 SUPPL-43 Labeling

Label is not available on this site.

06/07/1991 SUPPL-42 Labeling

Label is not available on this site.

05/15/1991 SUPPL-41 Labeling

Label is not available on this site.

12/26/1989 SUPPL-39 Labeling

Label is not available on this site.

10/13/1989 SUPPL-38 Labeling

Label is not available on this site.

09/22/1988 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

09/22/1988 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/02/1988 SUPPL-31 Bioequivalence

Label is not available on this site.

02/21/1984 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

04/06/1982 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

PREDNISONE

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English