FDA Orange Book · active-ingredient family
Dapiprazole hydrochloride
Dapiprazole hydrochloride is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DAPIPRAZOLE HYDROCHLORIDE · NDA 019849
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DAPIPRAZOLE HYDROCHLORIDERLD | FERA PHARMS | NDA 019849 | — | Dec 31, 1990 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DAPIPRAZOLE HYDROCHLORIDE | BARADAINA LLC | ANDA 204902 | — | May 30, 2019 |
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.
Dapiprazole hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
