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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218497
Company: NOVITIUM PHARMA

Products on ANDA 218497

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No
NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218497

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/12/2024	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
10/25/2024	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 218497

NAPROXEN

TABLET, DELAYED RELEASE;ORAL; 375MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EC-NAPROSYN	NAPROXEN	375MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	020067	ATNAHS PHARMA US
NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	075390	AUROBINDO PHARMA USA
NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	218497	NOVITIUM PHARMA
NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	091432	NUVO PHARMS INC
NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	075227	TEVA
NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216908	TP ANDA HOLDINGS

TABLET, DELAYED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EC-NAPROSYN	NAPROXEN	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	020067	ATNAHS PHARMA US
NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	075390	AUROBINDO PHARMA USA
NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	218497	NOVITIUM PHARMA
NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	091432	NUVO PHARMS INC
NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	075227	TEVA
NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	216908	TP ANDA HOLDINGS

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