Animal NDC 54771-3903-2 Synovex C
Progesterone And Estradiol Benzoate

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-3903-2
Proprietary Name Synovex C 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 Progesterone 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 to each steer or heifer at each implanting. Approved implantation technique is fully described in the package insert.NOTE: Never sacrifice careful, clean technique for speed of implantation.
Active Ingredient(s)
  • Estradiol Benzoate
  • Progesterone
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 NADA009576 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 C Images

Synovex C 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



Withdrawal Periods And Residue Warnings



No withdrawal period is required when used according to labeling. Do not use in beef calves less than 45 days of age, dairy calves, and veal calves. Do not use in bull calves intended for reproduction. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Implant pellets subcutaneously in ear only. Any other location is a violation of Federal Law. Do not attempt salvage of implanted site for human or animal food.


User Safety Warnings



Not for use in humans. Keep out of reach of children.


Animal Safety Warnings



Bulling has occasionally been reported in implanted steers and heifers. Vaginal and rectal prolapse, udder development, ventral edema and elevated tailheads have occasionally been reported in heifers administered SYNOVEX® C implants.


Directions



Implant complete contents of one cartridge cell to each steer or heifer at each implanting. Approved implantation technique is fully described in the package insert.

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


Indications For Use



• For increased rate of weight gain in beef calves 45 days of age and older and weighing up to 400 lbs.
• For increased rate of weight gain in growing beef steers fed in confinement for slaughter in a reimplantation program where SYNOVEX® C is the first implant and a SYNOVEX® S implant is administered approximately 70 days later.
• Other than as described on the labeling, this implant is not approved for repeated implantation (reimplantation) with any other cattle ear implant as safety and effectiveness have not been evaluated.

Do not use in calves less than 45 days of age or veal calves because effectiveness and safety have not been evaluated.
Do not use in animals intended for subsequent breeding, or in dairy cows.


Storage



Store at controlled room temperature 20° - 25°C (68° - 77°F) with excursions between 15°-30°C (59°-86°F). Avoid excessive heat or humidity.


Questions/Comments?



For a copy of the Safety Data Sheet or to report side effects, contact Zoetis Inc. at 1-888-963-8471. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.


Principal Display Panel - 10 Cartridge Implant Carton



40039892


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