Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 216908
Company: TULEX PHARMS INC

Products on ANDA 216908

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 216908

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/31/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216908

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