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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213386
Company: AMNEAL

Products on ANDA 213386

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	AB	No	No
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213386

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/24/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213386

PREDNISONE

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	213386	AMNEAL
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	215672	AUROBINDO PHARMA LTD
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	212629	GRANULATION TECH
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	Yes	AB	084122	HIKMA
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	040362	JUBILANT CADISTA
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	088832	MYLAN
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	211575	NOVITIUM PHARMA
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	208412	STRIDES PHARMA
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	089247	SUN PHARM INDUSTRIES
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	040256	VINTAGE PHARMS
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	085162	WATSON LABS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	No	AB	213386	AMNEAL
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	No	AB	215672	AUROBINDO PHARMA LTD
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	No	AB	212629	GRANULATION TECH
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	Yes	AB	087342	HIKMA
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	No	AB	040362	JUBILANT CADISTA
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	No	AB	083677	MYLAN
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	No	AB	211575	NOVITIUM PHARMA
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	No	AB	208412	STRIDES PHARMA
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	No	AB	089247	SUN PHARM INDUSTRIES
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	No	AB	040392	VINTAGE PHARMS
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	No	AB	085161	WATSON LABS

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