Orange Book product · Brand (NDA)
OPHTHAINE
PROPARACAINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
PROPARACAINE HYDROCHLORIDE
Strength
0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 008883
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- —OPHTHETICBrand (NDA)
NDA 012583 · ALLERGAN
- 2025PROPARACAINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219294 · MICRO LABS
- 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.
