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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078253
Company: NORTHSTAR HLTHCARE

Products on ANDA 078253

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	AB	No	No
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078253

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/11/2007	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/23/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
05/01/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
05/01/2015	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/31/2011	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 078253

ALLOPURINOL

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	203154	ACCORD HLTHCARE
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	077353	CHARTWELL
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	214443	HARMAN FINOCHEM
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	217748	HETERO LABS LTD V
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	204467	INDOCO
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	090637	IPCA LABS LTD
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	018659	MYLAN
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	078253	NORTHSTAR HLTHCARE
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	071450	SUN PHARM INDUSTRIES
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	211820	UNICHEM
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	075798	VINTAGE PHARMS
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	018832	WATSON LABS
ALLOPURINOL	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	210117	ZYDUS PHARMS
LOPURIN	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	No	AB	071586	DR REDDYS LA
ZYLOPRIM	ALLOPURINOL	100MG	TABLET;ORAL	Prescription	Yes	AB	016084	CASPER PHARMA LLC

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	203154	ACCORD HLTHCARE
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	077353	CHARTWELL
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	214443	HARMAN FINOCHEM
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	217748	HETERO LABS LTD V
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	204467	INDOCO
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	090637	IPCA LABS LTD
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	018659	MYLAN
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	078253	NORTHSTAR HLTHCARE
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	071450	SUN PHARM INDUSTRIES
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	211820	UNICHEM
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	075798	VINTAGE PHARMS
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	018877	WATSON LABS
ALLOPURINOL	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	210117	ZYDUS PHARMS
LOPURIN	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	No	AB	071587	DR REDDYS LA
ZYLOPRIM	ALLOPURINOL	300MG	TABLET;ORAL	Prescription	Yes	AB	016084	CASPER PHARMA LLC

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