Drugs@FDA: FDA Approved Drug Products

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

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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