Basic Information
Mirtazapine
53808-0646
Regulatory Information
53808-0646
ANDA076921
C73584
September 25, 2013
USA
Mirtazapine Tablets, USP7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
Active Ingredients
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)
Code: RFW2ET671P
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
COLLOIDAL SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED
Code: 2165RE0K14
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
HYPROMELLOSE 2910 (6 MPA.S)
Code: 0WZ8WG20P6
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
Active Moieties
MIRTAZAPINE
Code: A051Q2099Q