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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209727
Company: STRIDES PHARMA

Products on ANDA 209727

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISONE	PREDNISONE	2.5MG	TABLET;ORAL	Prescription	AB	No	No
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209727

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 209727

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	No	AB	211495	GENEYORK PHARMS
PREDNISONE	PREDNISONE	2.5MG	TABLET;ORAL	Prescription	No	AB	087801	HIKMA
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

TABLET;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;ORAL	Prescription	No	AB	213385	AMNEAL
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	215672	AUROBINDO PHARMA LTD
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	211495	GENEYORK PHARMS
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	080352	HIKMA
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	040362	JUBILANT CADISTA
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	080292	MYLAN
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	211575	NOVITIUM PHARMA
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	209727	STRIDES PHARMA
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	089247	SUN PHARM INDUSTRIES
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	040256	VINTAGE PHARMS
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	080356	WATSON LABS

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