FDA Orange Book · active-ingredient family
Nefazodone hydrochloride
Nefazodone hydrochloride is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SERZONE · NDA 020152
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SERZONERLD×6 | BRISTOL MYERS SQUIBB | NDA 020152 | — | Dec 22, 1994 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEFAZODONE HYDROCHLORIDE×5 | ANI PHARMS | ANDA 076072 | — | Sep 16, 2003 | |
| NEFAZODONE HYDROCHLORIDE×4 | AUROBINDO PHARMA USA | ANDA 076129 | — | Sep 16, 2003 | |
| NEFAZODONE HYDROCHLORIDE×5 | CHARTWELL RX | ANDA 076302 | — | Sep 16, 2003 | |
| NEFAZODONE HYDROCHLORIDE×5 | DR REDDYS LABS INC | ANDA 076309 | — | Sep 16, 2003 | |
| NEFAZODONE HYDROCHLORIDE×5 | IVAX SUB TEVA PHARMS | ANDA 075763 | — | Sep 16, 2003 | |
| NEFAZODONE HYDROCHLORIDE×5 | ROXANE | ANDA 076196 | — | Sep 16, 2003 | |
| NEFAZODONE HYDROCHLORIDE×5 | SUN PHARM INDS LTD | ANDA 076409 | — | Sep 16, 2003 | |
| NEFAZODONE HYDROCHLORIDE×5 | TEVA | ANDA 076037 | — | Sep 16, 2003 | |
| NEFAZODONE HYDROCHLORIDE×4 | WATSON LABS | ANDA 076073 | — | Sep 16, 2003 |
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.
Nefazodone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
