FDA Orange Book · active-ingredient family
Prednisolone acetate; sulfacetamide sodium
Prednisolone acetate; sulfacetamide sodium is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BLEPHAMIDE · NDA 012813
2
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · ointment, suspension, suspension/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BLEPHAMIDERLD | ALLERGAN | NDA 012813 | — | Approved Prior to Jan 1, 1982 | |
| METIMYD×2 | SCHERING | NDA 010210 | — | Sep 09, 1984 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CETAPRED | ALCON | ANDA 087771 | — | Aug 06, 1993 | |
| BLEPHAMIDE S.O.P. | ALLERGAN | ANDA 087748 | — | Dec 03, 1986 | |
| PREDSULFAIR II | PHARMAFAIR | ANDA 088837 | — | Dec 24, 1985 | |
| VASOCIDIN | NOVARTIS | ANDA 088791 | — | Oct 05, 1984 | |
| PREDAMIDE | EPIC PHARMA LLC | ANDA 088059 | — | Jul 29, 1983 | |
| PREDSULFAIR | PHARMAFAIR | ANDA 088007 | — | Apr 19, 1983 | |
| PREDSULFAIR | PHARMAFAIR | ANDA 088032 | — | Apr 15, 1983 | |
| SULPHRIN | BAUSCH AND LOMB | ANDA 088089 | — | Dec 28, 1982 | |
| ISOPTO CETAPRED | ALCON | ANDA 087547 | — | Approved Prior to Jan 1, 1982 |
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 acetate; sulfacetamide sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
