FDA Orange Book · active-ingredient family
Purified water
Purified water: 1 brand, 0 generics; first approved Sep 01, 2011.
Brand only
Generic status & protection
No listed patents or exclusivity: brand product(s) only.
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
1
Brand (NDA) products
Originator applications
- NIAGARA PHARMSNDA 0223052011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 98.3% SOLUTION OPHTHALMIC OTC —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
15 yr 1 mo ago
Most recent approval
15 yr 1 mo ago
All 1 application were approved in 2011.
Brand (NDA) 1100%
Generic (ANDA) 00%
Purified water: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
