Orange Book product · Generic (ANDA)
EPINASTINE HYDROCHLORIDE
EPINASTINE HYDROCHLORIDE
At a glance
Dec 07, 2016
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 07, 2016
9 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
EPINASTINE HYDROCHLORIDE
Strength
0.05%
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
ANDA 203384
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
- 2011EPINASTINE HYDROCHLORIDEGeneric (ANDA)
ANDA 090919 · APOTEX
- 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.
