Tulissin 25: Product Information (Page 3 of 3)

STORAGE CONDITIONS:

Store at or below 30°C (86°F). Use within 45 days of first puncture and puncture a maximum of 30 times. Consider using automatic injection equipment or a repeater syringe. When using a needle or draw-off spike larger than 16 gauge, discard any remaining product immediately after use.

HOW SUPPLIED

TULISSIN 25 (tulathromycin injection) Injectable Solution is available in the following package sizes:
50 mL vial
100 mL vial
250 mL vial

Manufactured for:
Virbac AH, Inc.
P.O. Box 162059, Fort Worth, TX 76161Made in France

Approved by FDA under ANADA # 200-668

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Virbac AH, Inc. at 1-800-338-3659 or us.virbac.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

©2021 Virbac Corporation. All Rights Reserved.

TULISSIN is a registered trademark of Virbac S.A.

Rev. 06/21

8838630

Label
(click image for full-size original)

TULISSIN 25 tulathromycin injection, solution
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:51311-002
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TULATHROMYCIN (TULATHROMYCIN) TULATHROMYCIN 25 mg
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51311-002-10 100 INJECTION, SOLUTION in 1 VIAL, MULTI-DOSE None
2 NDC:51311-002-25 250 INJECTION, SOLUTION in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200668 12/15/2021
Labeler — Virbac AH, Inc. (131568396)
Registrant — Virbac AH, Inc. (131568396)

Revised: 01/2022 Virbac AH, Inc.

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