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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020298
Company: MYLAN

Products on NDA 020298

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALOPRIM	ALLOPURINOL SODIUM	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020298

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/17/1996	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2020	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298Orig1s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020298Orig1s013ltr.pdf
02/17/2022	SUPPL-12	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF) Patient Package Insert (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020298s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020298Orig1s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020298Orig1s012lbl.pdf
08/28/2020	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020298Orig1s010ltr.pdf
05/13/2015	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
08/09/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
01/28/2000	SUPPL-2	Manufacturing (CMC)-Control		Label is not available on this site.
05/12/2000	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020298Orig1s001.pdf

Labels for NDA 020298

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/17/2022	SUPPL-12	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020298s012lbl.pdf
02/17/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020298s012lbl.pdf
12/16/2020	SUPPL-13	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298Orig1s013lbl.pdf
12/16/2020	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298Orig1s013lbl.pdf
08/28/2020	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020298s010lbl.pdf
05/12/2000	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/020298Orig1s001.pdf

Therapeutic Equivalents for NDA 020298

ALOPRIM

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

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