Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208363
Company: PURACAP PHARM LLC

Products on ANDA 208363

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 208363

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/15/2018	ORIG-1	Approval		STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208363Orig1s000ApprovRoutingSummary.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/13/2019	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

NAPROXEN SODIUM

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

CAPSULE;ORAL; EQ 200MG BASE

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE;ORAL	Over-the-counter	Yes	021920	BIONPHARMA
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE;ORAL	Over-the-counter	No	202807	CATALENT
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE;ORAL	Over-the-counter	No	214463	PATHEON SOFTGELS
NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE;ORAL	Over-the-counter	No	208363	PURACAP PHARM LLC