Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 087801
Company: HIKMA

Products on ANDA 087801

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISONE	PREDNISONE	2.5MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087801

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/22/1982	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-31	Labeling		Label is not available on this site.
08/28/1996	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
07/13/1995	SUPPL-21	Labeling		Label is not available on this site.
06/09/1997	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
06/09/1997	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
06/09/1997	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
06/09/1995	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
02/22/1995	SUPPL-16	Labeling		Label is not available on this site.
10/07/1994	SUPPL-15	Labeling		Label is not available on this site.
03/30/1994	SUPPL-14	Labeling		Label is not available on this site.
06/05/1991	SUPPL-13	Labeling		Label is not available on this site.
12/28/1989	SUPPL-11	Labeling		Label is not available on this site.
11/21/1989	SUPPL-10	Labeling		Label is not available on this site.
03/28/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
03/28/1988	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/01/1984	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 087801

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	Yes	AB	087801	HIKMA
PREDNISONE	PREDNISONE	2.5MG	TABLET;ORAL	Prescription	No	AB	040362	JUBILANT CADISTA
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