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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212629
Company: POINTVIEW HLDINGS

Products on ANDA 212629

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	AB	No	No
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 212629

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/05/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2023	SUPPL-3			Label is not available on this site.
12/05/2023	SUPPL-2			Label is not available on this site.
06/07/2024	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 212629

PREDNISONE

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	Yes	AB	080352	HIKMA
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	040362	JUBILANT CADISTA
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	083677	MYLAN
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	211575	NOVITIUM PHARMA
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	040256	PH HEALTH
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	212629	POINTVIEW HLDINGS
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	208412	STRIDES PHARMA
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	089247	SUN PHARM INDUSTRIES
PREDNISONE	PREDNISONE	5MG	TABLET;ORAL	Prescription	No	AB	080356	WATSON LABS

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	Yes	AB	080352	HIKMA
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	040362	JUBILANT CADISTA
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	083677	MYLAN
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	211575	NOVITIUM PHARMA
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	040256	PH HEALTH
PREDNISONE	PREDNISONE	10MG	TABLET;ORAL	Prescription	No	AB	212629	POINTVIEW HLDINGS
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	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	Yes	AB	080352	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	040392	PH HEALTH
PREDNISONE	PREDNISONE	20MG	TABLET;ORAL	Prescription	No	AB	212629	POINTVIEW HLDINGS
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	085161	WATSON LABS

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