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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075390
Company: AUROBINDO PHARMA USA

Products on ANDA 075390

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 075390

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2001	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-390_Naproxen_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75390ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-390_Naproxen.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/19/2020	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/19/2020	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/19/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/23/2008	SUPPL-3	Labeling		Label is not available on this site.
09/25/2007	SUPPL-2	Labeling		Label is not available on this site.

Labels for ANDA 075390

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-390_Naproxen_prntlbl.pdf

Therapeutic Equivalents for ANDA 075390

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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