Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215671
Company: AUROBINDO PHARMA LTD

Products on ANDA 215671

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215671

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2021	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
06/05/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 215671

PREDNISONE

TABLET;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;ORAL	Prescription	No	AB	213385	AMNEAL
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	No	AB	215671	AUROBINDO PHARMA LTD
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	Yes	AB	080352	HIKMA
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	No	AB	040611	JUBILANT CADISTA
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	No	AB	215246	NOVITIUM PHARMA
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	No	AB	040584	PH HEALTH
PREDNISONE	PREDNISONE	1MG	TABLET;ORAL	Prescription	No	AB	210785	STRIDES PHARMA