TULAVEN: Product Information (Page 4 of 4)

Principal Display Panel — 50 mL Vial and Carton

TULAVEN™ 100

(tulathromycin injection)

Injectable Solution

Antibiotic

100 mg of tulathromycin/mL

For use in beef cattle (including suckling calves), non-lactating dairy cattle (including dairy calves), veal calves, and swine. Not for use in female dairy cattle 20 months of age or older.

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Approved by FDA under ANADA # 200-711

Net Contents:

50 mL

50 mL Vial Label
(click image for full-size original)
50 mL Unit Carton
(click image for full-size original)

Principal Display Panel — 100 mL Vial and Carton

TULAVEN™ 100

(tulathromycin injection)

Injectable Solution

Antibiotic

100 mg of tulathromycin/mL

For use in beef cattle (including suckling calves), non-lactating dairy cattle (including dairy calves), veal calves, and swine. Not for use in female dairy cattle 20 months of age or older.

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Approved by FDA under ANADA # 200-711

Net Contents:

100 mL

100 mL Bottle Label
(click image for full-size original)

100 mL Unit Carton Label
(click image for full-size original)

Principal Display Panel — 250 mL Vial and Carton

TULAVEN™ 100

(tulathromycin injection)

Injectable Solution

Antibiotic

100 mg of tulathromycin/mL

For use in beef cattle (including suckling calves), non-lactating dairy cattle (including dairy calves), veal calves, and swine. Not for use in female dairy cattle 20 months of age or older.

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Approved by FDA under ANADA # 200-711

Net Contents:

250 mL

250 mL Bottle Label
(click image for full-size original)
250 mL Unit Carton Label
(click image for full-size original)

Principal Display Panel — 500 mL Vial and Carton

TULAVEN™ 100

(tulathromycin injection)

Injectable Solution

Antibiotic

100 mg of tulathromycin/mL

For use in beef cattle (including suckling calves), non-lactating dairy cattle (including dairy calves), veal calves, and swine. Not for use in female dairy cattle 20 months of age or older.

CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Approved by FDA under ANADA # 200-711

Net Contents:

500 mL

500 mL Bottle Label
(click image for full-size original)
500 mL Unit Carton Label
(click image for full-size original)
TULAVEN
tulathromycin solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:13744-522
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TULATHROMYCIN (TULATHROMYCIN) TULATHROMYCIN 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MONOTHIOGLYCEROL 5 mg in 1 mL
PROPYLENE GLYCOL 500 mg in 1 mL
ANHYDROUS CITRIC ACID 19.2 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13744-522-05 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 50 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (13744-522-05)
2 NDC:13744-522-10 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
2 100 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (13744-522-10)
3 NDC:13744-522-25 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
3 250 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (13744-522-25)
4 NDC:13744-522-50 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
4 500 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (13744-522-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200711 01/10/2022
Labeler — Ceva Sante Animale (261126049)
Registrant — Ceva Sante Animale (261126049)

Revised: 01/2022 Ceva Sante Animale

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