FDA Orange Book · active-ingredient family
Prednisolone sodium phosphate; sulfacetamide sodium
Prednisolone sodium phosphate; sulfacetamide sodium is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VASOCIDIN · NDA 018988
1
Brand (NDA)
3
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VASOCIDINRLD | NOVARTIS | NDA 018988 | — | Aug 26, 1988 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SULSTER | EPIC PHARMA LLC | ANDA 074511 | — | Jul 30, 1996 | |
| SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE | BAUSCH AND LOMB | ANDA 074449 | — | Dec 29, 1995 | |
| SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE | GENUS | ANDA 073630 | — | May 27, 1993 |
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.
Prednisolone sodium phosphate; sulfacetamide sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
