Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 087800
Company: HIKMA

Products on ANDA 087800

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 087800

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-36	Labeling		Label is not available on this site.
08/28/1996	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
07/13/1995	SUPPL-24	Labeling		Label is not available on this site.
06/09/1997	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
06/09/1997	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
06/09/1997	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/09/1995	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
02/22/1995	SUPPL-19	Labeling		Label is not available on this site.
10/07/1994	SUPPL-18	Labeling		Label is not available on this site.
03/30/1994	SUPPL-17	Labeling		Label is not available on this site.
05/14/1992	SUPPL-16	Labeling		Label is not available on this site.
06/05/1991	SUPPL-15	Labeling		Label is not available on this site.
12/26/1989	SUPPL-13	Labeling		Label is not available on this site.
10/13/1989	SUPPL-12	Labeling		Label is not available on this site.
05/20/1992	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/28/1988	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
07/28/1988	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 087800

PREDNISONE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	No	AB	213385	AMNEAL
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	No	AB	215671	AUROBINDO PHARMA LTD
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	Yes	AB	087800	HIKMA
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	No	AB	040611	JUBILANT CADISTA
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	No	AB	215246	NOVITIUM PHARMA
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	No	AB	210785	STRIDES PHARMA
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	No	AB	040584	VINTAGE PHARMS