Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075227
Company: TEVA

Products on ANDA 075227

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 075227

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/1998	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75227ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/06/2019	SUPPL-20	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/06/2019	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/06/2019	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
09/02/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/25/2008	SUPPL-9	Labeling		Label is not available on this site.
05/19/2006	SUPPL-8	Labeling		Label is not available on this site.
02/17/2006	SUPPL-7	Labeling		Label is not available on this site.
12/02/1999	SUPPL-3	Manufacturing (CMC)-Facility		Label is not available on this site.
12/02/1999	SUPPL-2	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 075227

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	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	TULEX PHARMS INC

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	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	TULEX PHARMS INC