Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212363
Company: GLAND PHARMA LTD

Products on ANDA 212363

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALLOPURINOL SODIUM	ALLOPURINOL SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212363

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2022	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
08/08/2022	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 212363

ALLOPURINOL SODIUM

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALLOPURINOL SODIUM	ALLOPURINOL SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	212363	GLAND PHARMA LTD
ALLOPURINOL SODIUM	ALLOPURINOL SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	076870	HIKMA
ALOPRIM	ALLOPURINOL SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	020298	MYLAN