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Animal NDC 68504-002-02 Gonabreed

Gonadorelin

Animal Product Information

Field Name Field Value
Animal NDC Code 68504-002-02
Proprietary Name Gonabreed 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 Gonadorelin 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 Parnell Technologies Pty Ltd
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Gonadorelin Acetate
Inactive Ingredient(s)
  • BENZYL ALCOHOL (LKG8494WBH)
  • SODIUM CHLORIDE (451W47IQ8X)
  • SODIUM PHOSPHATE, MONOBASIC (3980JIH2SW)
  • SODIUM PHOSPHATE, DIBASIC (GR686LBA74)
  • HYDROCHLORIC ACID (QTT17582CB)
  • SODIUM HYDROXIDE (55X04QC32I)
  • WATER (059QF0KO0R)
  • BENZYL ALCOHOL (LKG8494WBH)
  • SODIUM CHLORIDE (451W47IQ8X)
  • SODIUM PHOSPHATE, MONOBASIC (3980JIH2SW)
  • SODIUM PHOSPHATE, DIBASIC (GR686LBA74)
  • HYDROCHLORIC ACID (QTT17582CB)
  • SODIUM HYDROXIDE (55X04QC32I)
  • WATER (059QF0KO0R)
Marketing Category ANADA - ABBREVIATED 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 ANADA200541 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.

Gonabreed Images

Gonabreed 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.

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GONAbreed®

(gonadorelin)

100 mcg/mL gonadorelin acetate Injectable Solution

For the treatment of cystic ovaries in dairy cattle

For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows and beef cows.

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


Description



DESCRIPTION:

GONAbreed is a sterile solution containing 100 micrograms of gonadorelin (GnRH) as gonadorelin acetate per milliliter suitable for intramuscular or intravenous administration according to the indication. Gonadorelin is a decapeptide composed of the sequence of amino acids –

5-oxoPro-His-Trp-Ser-Tyr-Gly-Leu-Arg-Pro-Gly-NH2 –

a molecular weight of 1182.32 and empirical formula C55H75N17O13. The acetate salt has a molecular weight of 60.05 and an empirical formula C55H75N17O13. C2H4O2.

Each mL of GONAbreed contains:
Gonadorelin (as gonadorelin acetate) 100 mcg
Benzyl alcohol 10 mg
Sodium chloride 7.47 mg
Sodium phosphate monobasic 8.3 mg
Sodium phosphate dibasic 4.8 mg
Water for injection, q.s.
pH adjusted with hydrochloric acid or sodium hydroxide.

Gonadorelin is the hypothalamic releasing factor responsible for the release of gonadotropins (e.g., luteinizing hormone [LH], follicle stimulating hormone [FSH]) from the anterior pituitary. Synthetic gonadorelin is physiologically and chemically identical to the endogenous bovine hypothalamic releasing factor.


Principal Display Panel - 20 Ml Bottle



GONAbreed®

(gonadorelin)

100 mcg/mL gonadorelin acetate Injectable Solution

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

APPROVED BY FDA UNDER ANADA # 200-541

PARNELL TECHNOLOGIES PTY. LTD.4/476 Gardeners Road Alexandria NSW 2015, Australia

Net contents: 20mL


Principal Display Panel - 20 Ml Carton



GONAbreed

(gonadorelin)

100 mcg/mL gonadorelin acetate
Injectable Solution

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

INDICATIONS FOR USE:
For the treatment of cystic ovaries in
dairy cattle.
For use with cloprostenol sodium to
synchronize estrous cycles to allow for fixed
time artificial insemination (FTAI) in
lactating dairy cows and beef cows.

APPROVED BY FDA UNDER ANADA # 200-541

PARNELL

living SCIENCE

Net contents: 1 x 20mL


Principal Display Panel - 100 Ml Bottle



GONAbreed®

(gonadorelin)

100 mcg/mL gonadorelin acetate Injectable Solution

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

APPROVED BY FDA UNDER ANADA # 200-541

PARNELL TECHNOLOGIES PTY. LTD.4/476 Gardeners Road Alexandria NSW 2015, Australia

Net contents: 100mL


Principal Display Panel - 100 Ml Carton



GONAbreed

(gonadorelin)

100 mcg/mL gonadorelin acetate
Injectable Solution

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

INDICATIONS FOR USE:
For the treatment of cystic ovaries in
dairy cattle.
For use with cloprostenol sodium to
synchronize estrous cycles to allow for
fixed time artificial insemination (FTAI) in
lactating dairy cows and beef cows.

APPROVED BY FDA UNDER ANADA # 200-541

PARNELL

living SCIENCE

Net contents: 1 x 100mL


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