Clomipramine Hydrochloride: Product Information (Page 4 of 4)

Storage Conditions:

Store in a dry place at controlled room temperature, between 59° and 77°F (15-25°C). Store unused tablets in the original closed container.

How Supplied:

Clomipramine Hydrochloride Tablets are available in 5, 20, 40 and 80 mg tablet strengths in color-coded packaging for oral administration to dogs.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Manufactured For:
Mizner Bioscience, LLC
Boca Raton, FL 33432, USA

Approved by FDA under ANADA # 200-635
500453-08 Iss. 02/2021

PRINCIPAL DISPLAY PANEL

Clomipramine hydrochloride
5 mg (2.75 -10.9 lbs. body weight)
FOR USE IN DOGS ONLY
CAUTION: Federal (USA) law restricts this
drug for use by or on the order of a
licensed veterinarian
Net contents: 30 tablets
5 mg each

clomipramine hydrochloride 5 mg (2.75-10.9 lbs. body weight)
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Clomipramine hydrochloride
20 mg (11 — 22 lbs. body weight)
FOR USE IN DOGS ONLY
CAUTION: Federal (USA) law restricts this
drug for use by or on the order of a
licensed veterinarian
Net contents: 30 tablets
20 mg each

clomipramine hydrochloride 20 mg (11-22 lbs. body weight)
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Clomipramine hydrochloride
40 mg (22.1 — 44 lbs. body weight)
FOR USE IN DOGS ONLY
CAUTION: Federal (USA) law restricts this
drug for use by or on the order of a
licensed veterinarian
Net contents: 30 tablets
40 mg each

clomipramine hydrochloride 40 mg (22.1-44 lbs. body weight)
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Clomipramine hydrochloride
80 mg (44 — 176 lbs. body weight)
FOR USE IN DOGS ONLY
CAUTION: Federal (USA) law restricts this
drug for use by or on the order of a
licensed veterinarian
Net contents: 30 tablets
80 mg each

clomipramine hydrochloride 80 mg (44-176 lbs. body weight)
(click image for full-size original)

CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86039-113
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 5 mg
Product Characteristics
Color BROWN (light brown speckled) Score 2 pieces
Shape OVAL (modified capsule shaped) Size 9mm
Flavor MEAT (beef) Imprint Code MB;113
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86039-113-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200635 12/15/2019
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86039-114
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 20 mg
Product Characteristics
Color BROWN (light brown speckled) Score 2 pieces
Shape OVAL (modified capsule shaped) Size 11mm
Flavor MEAT (beef) Imprint Code MB;114
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86039-114-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200635 12/15/2019
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86039-115
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 40 mg
Product Characteristics
Color BROWN (light brown speckled) Score 2 pieces
Shape OVAL (modified capsule shaped) Size 15mm
Flavor MEAT (beef) Imprint Code MB;115
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86039-115-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200635 12/15/2019
CLOMIPRAMINE HYDROCHLORIDE clomipramine hydrochloride tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86039-116
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE) CLOMIPRAMINE HYDROCHLORIDE 80 mg
Product Characteristics
Color BROWN (light brown speckled) Score 2 pieces
Shape OVAL (modified capsule shaped) Size 15mm
Flavor MEAT (beef) Imprint Code MB;116
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86039-116-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200635 12/15/2019
Labeler — Mizner Bioscience, LLC (104644394)

Revised: 04/2021 Mizner Bioscience, LLC

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