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Animal NDC 54771-2011-1 Synovex One

Trenbolone Acetate And Estradiol Benzoate

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-2011-1
Proprietary Name Synovex One What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Trenbolone Acetate And Estradiol Benzoate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Otc Animal Drug
Usage Information
    Implant complete contents of one cartridge cell per steer or heifer. Approved implantation technique is fully described in the fold-out carton section.NOTE: Never sacrifice careful, clean technique for speed of implantation.
Active Ingredient(s)
  • Estradiol Benzoate
  • Trenbolone Acetate
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Synovex One Images

Synovex One Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



SYNOVEX ONE Grass (trenbolone acetate and estradiol benzoate extended-release implants) is a growth promoting implant containing 150 mg of trenbolone acetate and 21 mg of estradiol benzoate with a porous polymer film coating that extends the pay-out period of the final formulation up to 200 days. Each implant consists of 6 pellets. Ten implants are provided in each cartridge.


Dosage



One implant (six pellets), containing 150 mg of trenbolone acetate and 21 mg of estradiol benzoate, is administered to each steer or heifer by subcutaneous implantation in the middle one‑third of the ear.

The ten-dose cartridge of SYNOVEX ONE Grass is designed to be used exclusively with a Synovex Applicator.


Withdrawal Period



No withdrawal period is required when used according to labeling.

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Implant pellets in ear only. Any other location is a violation of Federal law. Do not attempt salvage of implanted site for human or animal food.


Warnings



NOT FOR USE IN HUMANS.

FOR ANIMAL USE ONLY.


Animal Safety Warning



Bulling, vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered SYNOVEX ONE Grass implants.


Directions



Implant complete contents of one cartridge cell per steer or heifer. Approved implantation technique is fully described in the fold-out carton section.

NOTE: Never sacrifice careful, clean technique for speed of implantation.


Storage



Store unopened product at controlled room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat and humidity. Use product before the expiration date on the label.

Once the pouch is opened, unused product may be stored in the end-folded pouch (away from light) for up to six months under refrigerated conditions 2°-8°C (36°-47°F) or at room temperature 20°-25°C (68°-77°F) with excursions between 15°-30°C (59°-86°F) for up to one month.


Disposal



SYNOVEX ONE Grass waste materials should be disposed of according to prescribed Federal, State, and Local guidelines.


Indications For Use



For increased rate of weight gain for up to 200 days in pasture steers and heifers (slaughter, stocker and feeder).

Do not use in veal calves. Effectiveness and animal safety in veal calves have not been established.

Not for use in dairy or beef replacement heifers.


Net Contents



One pouch contains ten 10-dose cartridges (100 implants).


Principal Display Panel - 10 Cartridge Implant Carton



SYNOVEX® ONE
GRASS
(trenbolone acetate and estradiol benzoate extended-release implants)
150 mg trenbolone acetate and 21 mg estradiol benzoate per implant

SUBCUTANEOUS IMPLANTS FOR PASTURE STEERS AND HEIFERS (SLAUGHTER, STOCKER AND FEEDER)

NOT FOR USE IN HUMANS.
FOR ANIMAL USE ONLY.

INDICATIONS FOR USE: For increased
rate of weight gain for up to 200 days in
pasture steers and heifers (slaughter,
stocker and feeder).

Do not use in veal calves. Effectiveness
and animal safety in veal calves have not
been established.

Not for use in dairy or beef replacement
heifers.

NET CONTENTS: One pouch contains
ten 10-dose cartridges (100 implants).

Manufactured By A
Non-Sterilizing Process

Keep this and all drugs out of the reach
of children.

Restricted Drug (California)—
Use Only As Directed.

IMPORTANT:
Read ALL sides of carton

Approved by FDA under NADA 141-348

zoetis

NET CONTENTS: 10 CARTRIDGES
Each Cartridge Contains 10 implants (100 implants total)


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.