Orange Book product · Brand (NDA)
ISOPTO CARPINE
PILOCARPINE HYDROCHLORIDE
At a glance
Jun 22, 2010
Approved
Brand (NDA)
Application
AT
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 22, 2010
16 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
PILOCARPINE HYDROCHLORIDE
Strength
1%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
AT
Application
NDA 200890
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2023QLOSIBrand (NDA)
NDA 217836 · ORASIS PHARMS
- 2021VUITYBrand (NDA)
NDA 214028 · ABBVIE
- 1994SALAGENBrand (NDA)
NDA 020237 · ADVANZ PHARMA
- 1984PILOPINE HSBrand (NDA)
NDA 018796 · ALCON
- 2025PILOCARPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217052 · FDC LTD
- 2025PILOCARPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217733 · AMNEAL
- 2020PILOCARPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214193 · AMNEAL
- 2019PILOCARPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210384 · SOMERSET THERAPS LLC
- 2019PILOCARPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212377 · AUROBINDO PHARMA USA
- 2017PILOCARPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204398 · RISING
- 2006PILOCARPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077248 · IMPAX LABS
- 2005PILOCARPINE HYDROCHLORIDEGeneric (ANDA)
ANDA 077220 · LANNETT CO INC
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.
