Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022305
Company: NIAGARA PHARMS
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 |
---|---|---|---|---|---|
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. |
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 |