Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202795
Company: RISING

Products on ANDA 202795

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.025%;0.3%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202795

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/24/2013	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202795Orig1s000ltr.pdf

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

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE

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

SOLUTION/DROPS;OPHTHALMIC; 0.025%;0.3%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.025%;0.3%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	No	202795	RISING
NAPHCON-A	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.025%;0.3%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	Yes	020226	ALCON
VISINE	NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	0.025%;0.3%	SOLUTION/DROPS;OPHTHALMIC	Over-the-counter	Yes	020485	JOHNSON AND JOHNSON