mirtazapine tablet film coated

1 INDICATIONS AND USAGE Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14 )] . Mirtazapine tablets are indicated for the treatment of major depressive disorder (MDD) in adults. ( 1 )

apotex corp.

FDA Reported Adverse Reactions
`[1] off label use` `[2] drug ineffective` `[3] fatigue` `[4] nausea` `[5] diarrhoea` `[6] condition aggravated` `[7] headache` `[8] fall` `[9] toxicity to various agents` `[10] malaise`

6 years ago

OVAL YELLOW Apo MI 15

6 years ago

Apo MI 15 OVAL YELLOW

16 HOW SUPPLIED/STORAGE AND HANDLING

MIRTAZAPINE tablets are supplied as:

MIRTAZAPINE Tablets, USP 15 mg are available for oral administration as pale yellow, oval-shaped, scored, film-coated tablets imprinted “APO” on one side and “MI” bisect “15” on the other side. They are supplied as follows: Bottles of 30 NDC 60505-0247-1 Bottles of 1,000 NDC 60505-0247-8

MIRTAZAPINE Tablets, USP 30 mg are available for oral administration as light pink, oval-shaped, scored, film-coated tablets imprinted “APO” on one side and “MI” bisect “30” on the other side. They are supplied as follows: Bottles of 30 NDC 60505-0248-1 Bottles of 1,000 NDC 60505-0248-8

MIRTAZAPINE Tablets, USP 45 mg are available for oral administration as white to off-white, oval-shaped, unscored, film-coated tablets imprinted “APO” on one side and “MI-45” on the other side. They are supplied as follows: Bottles of 30 NDC 60505-0249-1 Bottles of 1,000 NDC 60505-0249-8 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

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