Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084283
Company: HIKMA

Products on ANDA 084283

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISONE	PREDNISONE	50MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084283

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/1977	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-41	Labeling		Label is not available on this site.
03/14/2003	SUPPL-33	Labeling		Label is not available on this site.
08/28/1996	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
07/13/1995	SUPPL-26	Labeling		Label is not available on this site.
06/09/1995	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
02/22/1995	SUPPL-24	Labeling		Label is not available on this site.
10/07/1994	SUPPL-23	Labeling		Label is not available on this site.
03/30/1994	SUPPL-22	Labeling		Label is not available on this site.
06/05/1991	SUPPL-21	Labeling		Label is not available on this site.
01/16/1990	SUPPL-18	Labeling		Label is not available on this site.
10/13/1989	SUPPL-17	Labeling		Label is not available on this site.
09/19/1989	SUPPL-16	Labeling		Label is not available on this site.
02/23/1988	SUPPL-14	Labeling		Label is not available on this site.
01/07/1988	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
01/07/1988	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/24/1984	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/22/1983	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
04/22/1983	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 084283

PREDNISONE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PREDNISONE	PREDNISONE	50MG	TABLET;ORAL	Prescription	No	AB	215672	AUROBINDO PHARMA LTD
PREDNISONE	PREDNISONE	50MG	TABLET;ORAL	Prescription	Yes	AB	084283	HIKMA
PREDNISONE	PREDNISONE	50MG	TABLET;ORAL	Prescription	No	AB	040362	JUBILANT CADISTA
PREDNISONE	PREDNISONE	50MG	TABLET;ORAL	Prescription	No	AB	211575	NOVITIUM PHARMA
PREDNISONE	PREDNISONE	50MG	TABLET;ORAL	Prescription	No	AB	208412	STRIDES PHARMA