FDA Orange Book · active-ingredient family
Proparacaine hydrochloride
Proparacaine hydrochloride is approved as 2 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OPHTHAINE · NDA 008883
2
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OPHTHAINERLD | APOTHECON | NDA 008883 | — | Approved Prior to Jan 1, 1982 | |
| OPHTHETICRLD | ALLERGAN | NDA 012583 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROPARACAINE HYDROCHLORIDE | MICRO LABS | ANDA 219294 | AT | Oct 20, 2025 | |
| PROPARACAINE HYDROCHLORIDE | MANKIND PHARMA | ANDA 219136 | AT | May 21, 2025 | |
| PROPARACAINE HYDROCHLORIDE | SOMERSET THERAPS LLC | ANDA 215816 | AT | Aug 09, 2024 | |
| PROPARACAINE HYDROCHLORIDE | RISING | ANDA 040277 | AT | Mar 16, 2000 | |
| PROPARACAINE HYDROCHLORIDE | BAUSCH AND LOMB INC | ANDA 040074 | AT | Sep 29, 1995 | |
| KAINAIR | PHARMAFAIR | ANDA 088087 | — | Jun 07, 1983 | |
| PARACAINE | OPTOPICS | ANDA 087681 | — | Aug 05, 1982 | |
| ALCAINE | ALCON LABS INC | ANDA 080027 | AT | Approved Prior to Jan 1, 1982 | |
| PROPARACAINE HYDROCHLORIDE | SOLA BARNES HIND | ANDA 084144 | — | Approved Prior to Jan 1, 1982 | |
| PROPARACAINE HYDROCHLORIDE | SOLA BARNES HIND | ANDA 084151 | — | 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.
Proparacaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
