MedPath
FDA Product

Mirtazapine

Product approved by U.S. Food and Drug Administration (US)

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

829348114

Active Ingredients

MIRTAZAPINE

Quantity: 15 mg in 1 1

Code: A051Q2099Q

Class Code: ACTIB

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

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