Prednisolone sodium phosphate; sulfacetamide sodium
Prednisolone sodium phosphate; sulfacetamide sodium: 1 brand, 3 generics; first approved Aug 26, 1988; generic available.
Generic available — 3 ANDA applications approved.
Brand (NDA) products
VASOCIDINRLDNOVARTISNDA 0189881988
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 0.23% PHOSPHATE;10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS | OPHTHALMIC | Discontinued | — |
Generic (ANDA) products (3)
EPIC PHARMA LLCANDA 0745111996
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 0.23% PHOSPHATE;10% | SOLUTION/DROPS | OPHTHALMIC | Discontinued | — |
BAUSCH AND LOMBANDA 0744491995
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 0.23% PHOSPHATE;10% | SOLUTION/DROPS | OPHTHALMIC | Rx | — |
GENUSANDA 0736301993
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 0.23% PHOSPHATE;10% | SOLUTION/DROPS | OPHTHALMIC | Discontinued | — |
Listed patents
Listed patents
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
Approvals span 1988–1996 across 4 FDA applications.
Prednisolone sodium phosphate; sulfacetamide sodium — 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 BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
