FDA Orange Book · active-ingredient family
Procaine hydrochloride
Procaine hydrochloride is approved in 12 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
0
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NOVOCAIN×2 | HOSPIRA | ANDA 085362 | — | Approved Prior to Jan 1, 1982 | |
| NOVOCAIN | HOSPIRA | ANDA 086797 | — | Approved Prior to Jan 1, 1982 | |
| PROCAINE HYDROCHLORIDE×2 | ABRAXIS PHARM | ANDA 080384 | — | Approved Prior to Jan 1, 1982 | |
| PROCAINE HYDROCHLORIDE×2 | ABRAXIS PHARM | ANDA 080421 | — | Approved Prior to Jan 1, 1982 | |
| PROCAINE HYDROCHLORIDE | BEL MAR | ANDA 080711 | — | Approved Prior to Jan 1, 1982 | |
| PROCAINE HYDROCHLORIDE | BEL MAR | ANDA 080756 | — | Approved Prior to Jan 1, 1982 | |
| PROCAINE HYDROCHLORIDE×2 | ELKINS SINN | ANDA 083315 | — | Approved Prior to Jan 1, 1982 | |
| PROCAINE HYDROCHLORIDE×2 | GD SEARLE LLC | ANDA 086202 | — | Approved Prior to Jan 1, 1982 | |
| PROCAINE HYDROCHLORIDE×2 | HOSPIRA | ANDA 080416 | — | Approved Prior to Jan 1, 1982 | |
| PROCAINE HYDROCHLORIDE×2 | MILES | ANDA 080415 | — | Approved Prior to Jan 1, 1982 | |
| PROCAINE HYDROCHLORIDE×2 | WATSON LABS | ANDA 080658 | — | Approved Prior to Jan 1, 1982 | |
| PROCAINE HYDROCHLORIDE×2 | WATSON LABS | ANDA 083535 | — | 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.
Procaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
