Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076913
Company: PHARM ASSOC

Products on ANDA 076913

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076913

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2005	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
04/16/2010	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/02/2009	SUPPL-4	Labeling		Label is not available on this site.
10/05/2007	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.

Therapeutic Equivalents for ANDA 076913

PREDNISOLONE SODIUM PHOSPHATE

SOLUTION;ORAL; EQ 15MG BASE/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	216715	AMNEAL
PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	203559	EDENBRIDGE PHARMS
PREDNISOLONE SODIUM PHOSPHATE	PREDNISOLONE SODIUM PHOSPHATE	EQ 15MG BASE/5ML	SOLUTION;ORAL	Prescription	No	AA	076913	PHARM ASSOC