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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022305
Company: NIAGARA PHARMS

Summary Review

Products on NDA 022305

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PUR-WASH	PURIFIED WATER	98.3%	SOLUTION;OPHTHALMIC	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022305

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/01/2011	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Letter (PDF) Review Summary Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022305s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022305_purwash_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022305Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/02/2026	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022305Orig1s008lbl.pdf
06/26/2025	SUPPL-7	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022305Orig1s007ltr.pdf
12/12/2019	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.
01/07/2015	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
09/26/2013	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 022305

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/02/2026	SUPPL-8	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022305Orig1s008lbl.pdf

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

PUR-WASH

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

SOLUTION;OPHTHALMIC; 98.3%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
PUR-WASH	PURIFIED WATER	98.3%	SOLUTION;OPHTHALMIC	Over-the-counter	Yes	022305	NIAGARA PHARMS

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