Orange Book product · Generic (ANDA)
PROPARACAINE HYDROCHLORIDE
PROPARACAINE HYDROCHLORIDE
At a glance
Oct 20, 2025
Approved
Generic (ANDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 20, 2025
8 mo ago
Today
Pharmaceutical detail
Active ingredient
PROPARACAINE HYDROCHLORIDE
Strength
0.5%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
ANDA 219294
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of PROPARACAINE HYDROCHLORIDE
- —OPHTHAINEBrand (NDA)
NDA 008883 · APOTHECON
- —OPHTHETICBrand (NDA)
NDA 012583 · ALLERGAN
- 2025PROPARACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219136 · MANKIND PHARMA
- 2024PROPARACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215816 · SOMERSET THERAPS LLC
- 2000PROPARACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040277 · RISING
- 1995PROPARACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040074 · BAUSCH AND LOMB INC
- 1983KAINAIRGeneric (ANDA)
ANDA 088087 · PHARMAFAIR
- 1982PARACAINEGeneric (ANDA)
ANDA 087681 · OPTOPICS
- —ALCAINEGeneric (ANDA)
ANDA 080027 · ALCON LABS INC
- —PROPARACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 084144 · SOLA BARNES HIND
- —PROPARACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 084151 · SOLA BARNES HIND
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.
