FDA Orange Book · active-ingredient family
Paromomycin sulfate
Paromomycin sulfate is approved in 5 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PAROMOMYCIN SULFATE | HERITAGE | ANDA 065173 | — | Dec 14, 2007 | |
| PAROMOMYCIN SULFATE | SUN PHARM INDS INC | ANDA 064171 | — | Jun 30, 1997 | |
| HUMATIN | KING PFIZER | ANDA 062310 | — | Approved Prior to Jan 1, 1982 | |
| HUMATIN | PARKEDALE | ANDA 060521 | — | Approved Prior to Jan 1, 1982 | |
| HUMATIN | PARKE DAVIS | ANDA 060522 | — | 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.
Paromomycin sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
