Epinastine hydrochloride FDA approval

Epinastine HCl assay content is NLT 99.5% and total impurity content of NMT 0.2%
CHEMICAL NAME:
3-amino-9,13b-dihydro-1H-dibenz[c,f]imidazo[1,5-a]azepine hydrochloride
STRUCTURE FORMULA:
MOLECULAR FORMULA:
Epinastine HCl:C
16
H
15
N
3
.HCl
MOLECULAR WEIGHT:
285.78
CAS NO:
80012-44-8
CLINICAL APPLICATIO:
A histamine H1 receptor antagonist. Epinastine Hydrochloride, a second generation antihistamine API, is clinically used for allergic rhinitis, urticaria, eczema, dermatisis, pruritis of skin, psoriasis, and allergic bronchial asthma et al. Epinastine Hydrochloride reveals a wide indication spectrum, a fast effect and a long action time.
CURRENT STATUS:
Epinastine Hydrochloride produced in CREDIT CHEMWERTH, with an assay content of NLT 99.5% and total impurity content of NMT 0.2%, is anticipating for FDAs inspection for cGMP compliance, and CREDIT CHEMWERTH already has DMF file.