Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212705
Company: AMNEAL

Products on ANDA 212705

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAPROXEN	NAPROXEN	25MG/ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212705

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/31/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212705

NAPROXEN

SUSPENSION;ORAL; 25MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NAPROSYN	NAPROXEN	25MG/ML	SUSPENSION;ORAL	Prescription	Yes	AB	018965	ATNAHS PHARMA US
NAPROXEN	NAPROXEN	25MG/ML	SUSPENSION;ORAL	Prescription	No	AB	212705	AMNEAL
NAPROXEN	NAPROXEN	25MG/ML	SUSPENSION;ORAL	Prescription	No	AB	215776	HETERO LABS LTD III
NAPROXEN	NAPROXEN	25MG/ML	SUSPENSION;ORAL	Prescription	No	AB	074190	HIKMA
NAPROXEN	NAPROXEN	25MG/ML	SUSPENSION;ORAL	Prescription	No	AB	211910	NOVITIUM PHARMA