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

Page 4 of 4 1 2 3 4

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2021. All Rights Reserved.