NDC Code(s) : 17033-440-07, 17033-440-21, 17033-441-07, 17033-441-21, 17033-442-07, 17033-442-21, 17033-443-07, 17033-443-21
Packager : Dechra Veterinary Products LLC

Category : PRESCRIPTION ANIMAL DRUG LABEL

DEA Schedule : none

Marketing Status : New Animal Drug Application

INGREDIENTS AND APPEARANCE

Clavacillinamoxicillin anhydrous and clavulanate potassium TABLET
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:17033-440
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amoxicillin anhydrous(UNII: 9EM05410Q9)
(amoxicillin anhydrous - UNII:9EM05410Q9) 		amoxicillin anhydrous50 mg
clavulanate potassium(UNII: Q42OMW3AT8)
(clavulanic acid - UNII:23521W1S24) 		clavulanic acid12.5 mg
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 7 mm
Flavor Imprint Code P1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:17033-440-075 in 1 CARTON
114 in 1 BLISTER PACK
2NDC:17033-440-2115 in 1 CARTON
214 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200592 01/10/2019
Clavacillinamoxicillin anhydrous and clavulanate potassium TABLET
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:17033-441
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amoxicillin anhydrous(UNII: 9EM05410Q9)
(amoxicillin anhydrous - UNII:9EM05410Q9) 		amoxicillin anhydrous100 mg
clavulanate potassium(UNII: Q42OMW3AT8)
(clavulanic acid - UNII:23521W1S24) 		clavulanic acid25 mg
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 9 mm
Flavor Imprint Code P2
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:17033-441-075 in 1 CARTON
114 in 1 BLISTER PACK
2NDC:17033-441-2115 in 1 CARTON
214 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200592 01/10/2019
Clavacillinamoxicillin anhydrous and clavulanate potassium TABLET
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:17033-442
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amoxicillin anhydrous(UNII: 9EM05410Q9)
(amoxicillin anhydrous - UNII:9EM05410Q9) 		amoxicillin anhydrous200 mg
clavulanate potassium(UNII: Q42OMW3AT8)
(clavulanic acid - UNII:23521W1S24) 		clavulanic acid50 mg
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code P3
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:17033-442-075 in 1 CARTON
114 in 1 BLISTER PACK
2NDC:17033-442-2115 in 1 CARTON
214 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200592 01/10/2019
Clavacillinamoxicillin anhydrous and clavulanate potassium TABLET
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:17033-443
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
amoxicillin anhydrous(UNII: 9EM05410Q9)
(amoxicillin anhydrous - UNII:9EM05410Q9) 		amoxicillin anhydrous300 mg
clavulanate potassium(UNII: Q42OMW3AT8)
(clavulanic acid - UNII:23521W1S24) 		clavulanic acid75 mg
Product Characteristics
Color YELLOW Score no score
Shape ROUND Size 13 mm
Flavor Imprint Code P4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:17033-443-075 in 1 CARTON
114 in 1 BLISTER PACK
2NDC:17033-443-2115 in 1 CARTON
214 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200592 01/10/2019

LABELER - Dechra Veterinary Products LLC(362142734)

PRINCIPAL DISPLAY PANEL

Clavacillin®
(amoxicillin and clavulanate potassium tablets), USP
62.5 mg

Veterinary Tablets

For use in dogs and cats

15 strips, 14 tablets each
210 tablets

62.5 mg

Each film-coated tablet contains amoxicillin trihydrate
equivalent to 50 mg of amoxicillin USP activity and 12.5 mg of
clavulanic acid USP as the potassium salt.

Caution: Federal law restricts this drug to use by or on the
order of a licensed veterinarian.

Approved by FDA under ANADA # 200-592

Dechra

PRINCIPAL DISPLAY PANEL - 62.5 mg Tablet Blister Pack Carton

PRINCIPAL DISPLAY PANEL

Clavacillin®
(amoxicillin and clavulanate potassium tablets), USP
125 mg

Veterinary Tablets

For use in dogs

15 strips, 14 tablets each
210 tablets

125 mg

Each film-coated tablet contains amoxicillin trihydrate
equivalent to 100 mg of amoxicillin USP activity and 25 mg of
clavulanic acid USP as the potassium salt.

Caution: Federal law restricts this drug to use by or on the
order of a licensed veterinarian.

Approved by FDA under ANADA # 200-592

Dechra

PRINCIPAL DISPLAY PANEL - 125 mg Tablet Blister Pack Carton

PRINCIPAL DISPLAY PANEL

Clavacillin®
(amoxicillin and clavulanate potassium tablets), USP
250 mg

Veterinary Tablets

For use in dogs

15 strips, 14 tablets each
210 tablets

250 mg

Each film-coated tablet contains amoxicillin trihydrate
equivalent to 200 mg of amoxicillin USP activity and 50 mg of
clavulanic acid USP as the potassium salt.

Caution: Federal law restricts this drug to use by or on the
order of a licensed veterinarian.

Approved by FDA under ANADA # 200-592

Dechra

PRINCIPAL DISPLAY PANEL - 250 mg Tablet Blister Pack Carton

PRINCIPAL DISPLAY PANEL

Clavacillin®
(amoxicillin and clavulanate potassium tablets), USP
375 mg

Veterinary Tablets

For use in dogs

15 strips, 14 tablets each
210 tablets

375 mg

Each film-coated tablet contains amoxicillin trihydrate
equivalent to 300 mg of amoxicillin USP activity and 75 mg of
clavulanic acid USP as the potassium salt.

Caution: Federal law restricts this drug to use by or on the
order of a licensed veterinarian.

Approved by FDA under ANADA # 200-592

Dechra

PRINCIPAL DISPLAY PANEL - 375 mg Tablet Blister Pack Carton