Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 088832
Company: MYLAN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
05/02/2019 SUPPL-35 Labeling-Package Insert

Label is not available on this site.

12/09/2002 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1998 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/29/1998 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/13/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

11/18/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/14/1994 SUPPL-12 Labeling

Label is not available on this site.

02/09/1994 SUPPL-11 Labeling

Label is not available on this site.

04/14/1994 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/14/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/06/1990 SUPPL-8 Labeling

Label is not available on this site.

02/13/1991 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/09/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/09/1994 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/09/1994 SUPPL-3 Labeling

Label is not available on this site.

10/06/1987 SUPPL-1 Manufacturing (CMC)

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 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

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