Orange Book product · Generic (ANDA)
EPINASTINE HYDROCHLORIDE
EPINASTINE HYDROCHLORIDE
At a glance
Oct 31, 2011
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 2011
14 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
EPINASTINE HYDROCHLORIDE
Strength
0.05%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
ANDA 090919
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EPINASTINE HYDROCHLORIDE
- 2003ELESTATBrand (NDA)
NDA 021565 · ALLERGAN
- 2017EPINASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 204055 · EPIC PHARMA LLC
- 2016EPINASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 203384 · CHARTWELL RX
- 2011EPINASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090951 · SOMERSET THERAPS LLC
- 2011EPINASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 091626 · SUN PHARM INDS
- 2011EPINASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090870 · PHARMOBEDIENT
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.
