Laverdia-CA1: Product Information (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 2.5 mg Tablet Bottle Label

LAVERDIA™-CA1
(verdinexor tablets)

2.5 mg per tablet

Antineoplastic
For Oral Use in Dogs Only
Indicated for the treatment of lymphoma in dogs

Conditionally approved by FDA pending a full
demonstration of effectiveness under application
number 141-526

CAUTION: Federal (USA) law restricts this drug to
use by or on the order of a licensed veterinarian.
Use only as directed. It is a violation of Federal
law to use this product other than as directed in the labeling.

50 Tablets

ANIVIVE

PRINCIPAL DISPLAY PANEL -- 2.5 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2.5 mg Tablet Bottle Carton

LAVERDIA™-CA1
(verdinexor tablets)

2.5 mg per tablet

Antineoplastic
For Oral Use in Dogs Only
Indicated for the treatment of lymphoma in dogs

Conditionally approved by FDA pending a
full demonstration of effectiveness under
application number 141-526

CAUTION: Federal (USA) law restricts this
drug to use by or on the order of a licensed
veterinarian. Use only as directed. It is a
violation of Federal law to use this productother than as directed in the labeling.

50 Tablets

ANIVIVE

Principal Display Panel -- 2.5 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Bottle Label

LAVERDIA™-CA1
(verdinexor tablets)

10 mg per tablet

Antineoplastic
For Oral Use in Dogs Only
Indicated for the treatment of lymphoma in dogs

Conditionally approved by FDA pending a full
demonstration of effectiveness under application
number 141-526

CAUTION: Federal (USA) law restricts this drug to
use by or on the order of a licensed veterinarian.
Use only as directed. It is a violation of Federal
law to use this product other than as directed in the labeling.

50 Tablets

ANIVIVE

PRINCIPAL DISPLAY PANEL -- 10 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Bottle Carton

LAVERDIA™-CA1
(verdinexor tablets)

10 mg per tablet

Antineoplastic
For Oral Use in Dogs Only
Indicated for the treatment of lymphoma in dogs

Conditionally approved by FDA pending a
full demonstration of effectiveness under
application number 141-526

CAUTION: Federal (USA) law restricts this
drug to use by or on the order of a licensed
veterinarian. Use only as directed. It is a
violation of Federal law to use this productother than as directed in the labeling.

50 Tablets

ANIVIVE

Principal Display Panel -- 10 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Label

LAVERDIA™-CA1
(verdinexor tablets)

50 mg per tablet

Antineoplastic
For Oral Use in Dogs Only
Indicated for the treatment of lymphoma in dogs

Conditionally approved by FDA pending a full
demonstration of effectiveness under application
number 141-526

CAUTION: Federal (USA) law restricts this drug to
use by or on the order of a licensed veterinarian.
Use only as directed. It is a violation of Federal
law to use this product other than as directed in the labeling.

50 Tablets

ANIVIVE

PRINCIPAL DISPLAY PANEL -- 50 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Carton

LAVERDIA™-CA1
(verdinexor tablets)

50 mg per tablet

Antineoplastic
For Oral Use in Dogs Only
Indicated for the treatment of lymphoma in dogs

Conditionally approved by FDA pending a
full demonstration of effectiveness under
application number 141-526

CAUTION: Federal (USA) law restricts this
drug to use by or on the order of a licensed
veterinarian. Use only as directed. It is a
violation of Federal law to use this productother than as directed in the labeling.

50 Tablets

ANIVIVE

Principal Display Panel -- 50 mg Tablet Bottle Carton
(click image for full-size original)
LAVERDIA-CA1 verdinexor tablet, coated
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86121-0001
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
verdinexor (verdinexor) verdinexor 2.5 mg
Inactive Ingredients
Ingredient Name Strength
Microcrystalline Cellulose
Croscarmellose Sodium
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
Magnesium Stearate
Sodium Lauryl Sulfate
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 7mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86121-0001-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 50 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (86121-0001-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
CONDITIONAL NADA NADA141526 01/11/2021
LAVERDIA-CA1 verdinexor tablet, coated
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86121-0002
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
verdinexor (verdinexor) verdinexor 10 mg
Inactive Ingredients
Ingredient Name Strength
Microcrystalline Cellulose
Croscarmellose Sodium
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
Magnesium Stearate
Sodium Lauryl Sulfate
Product Characteristics
Color BLUE Score no score
Shape OVAL Size 9mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86121-0002-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 50 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (86121-0002-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
CONDITIONAL NADA NADA141526 01/11/2021
LAVERDIA-CA1 verdinexor tablet, coated
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86121-0003
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
verdinexor (verdinexor) verdinexor 50 mg
Inactive Ingredients
Ingredient Name Strength
Microcrystalline Cellulose
Croscarmellose Sodium
POVIDONE, UNSPECIFIED
SILICON DIOXIDE
Magnesium Stearate
Sodium Lauryl Sulfate
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 15mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:86121-0003-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 50 TABLET, COATED in 1 BOTTLE, PLASTIC This package is contained within the CARTON (86121-0003-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
CONDITIONAL NADA NADA141526 01/11/2021
Labeler — Anivive Lifesciences, Inc (080144185)

Revised: 04/2021 Anivive Lifesciences, Inc

Page 3 of 3 1 2 3

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.