Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204867
Company: ACTAVIS LABS FL INC

Products on ANDA 204867

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISONE	PREDNISONE	1MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No
PREDNISONE	PREDNISONE	2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No
PREDNISONE	PREDNISONE	5MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204867

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/25/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 204867

PREDNISONE

TABLET, DELAYED RELEASE;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, DELAYED RELEASE;ORAL	Prescription	No	AB	204867	ACTAVIS LABS FL INC
RAYOS	PREDNISONE	1MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	202020	HORIZON

TABLET, DELAYED RELEASE;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PREDNISONE	PREDNISONE	2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	204867	ACTAVIS LABS FL INC
RAYOS	PREDNISONE	2MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	202020	HORIZON

TABLET, DELAYED RELEASE;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PREDNISONE	PREDNISONE	5MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	204867	ACTAVIS LABS FL INC
RAYOS	PREDNISONE	5MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	202020	HORIZON