Complete Up To Date Information about Gainpro Type A Medicated Article.
NADA Number: 141-034 | |
| Proprietary Name |
Gainpro® Type A Medicated Article |
|---|---|
| Sponsor |
Huvepharma AD |
| Sponsor Address |
33 James Boucher Blvd. Sophia 1407, Bulgaria |
| Ingredients |
Bambermycins |
| Species |
Cattle, beef, heifers Cattle, dairy, heifers Cattle, pastured (slaughter, stocker, feeder, beef and heifers) beef replacement heifers |
| Routes of Administration |
Per Os |
| Dose Form |
Medicated feed |
| Drug Form |
Type A Medicated Article |
| Dispensing Status |
OTC |
| Exclusivity |
Granted for the manufacture of free choice Type C feed from Type A product for pasture cattle. Granted for the use of a Type A medicated article to make a free-choice Type C medicated feed. Granted for increased rate of weight gain in pasture cattle when fed daily in at least one pound and not more than ten pounds of supplemental feed (Type C Medicated feed). Granted for use in a new species (dairy and beef heifers). |
|
Dosage Amount, Indications & Limitations |
558.95 Bambermycins. Specifications: Type A medicated articles. Conditions of use: Cattle (pasture: slaughter, stocker, feeder, dairy heifers and beef replacement heifers) Amount: 2 to 40 grams per ton of feed. Indications: For increased rate of weight gain. Limitations: Feed continuously at a rate of 10 to 40 milligrams of bambermycins per head per day in at least 1 pound and not more than 10 pounds of Type C free choice medicated feed. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day. Specifications: Used as a free-choice Type C medicated loose mineral feed as follows: Ingredient International Feed No. Percent __________________________________________ Deflorinated phosphate 6-01-080 42.50 (20.5 percent Ca, 18.5 percent P) Sodium chloride (salt) 6-04-152 20.10 Calcium carbonate 6-01-069 15.24 (38 percent Calcium) Corn distillers dried 5-28-236 9.57 grains w/solubles Magnesium Oxide 6-02-069 5.15 Vitamin and trace mineral premix * 3.72 Mineral Oil 1.00 Yeast (primary dehydrated yeast) 7-05-533 0.75 Bambermycins Type A article (10 grams per pound) 0.60 Iron Oxide 6-02-431 0.50 Magnesium Sulfate 6-02-758 0.32 (67 percent) Selenium premix 0.21 (270 milligrams per pound) Copper sulfate 6-01-720 0.18 Potassium sulfate 6-06-098 0.16 (0.33 percent) __________________________________________ *Content of vitamin/trace mineral premix may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920 Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18). Conditions of use: Cattle (pasture: slaughter, stocker, feeder, dairy heifers and beef replacement heifers) Amount: 120 grams per ton of feed. Indications: For increased rate of gain. Limitations: For free choice feeding. Feed a non-medicated commercial mineral product for 6 weeks to stabilize consumption between 2.66 and 10.66 ounces per head per day. Feed continuously to provide 10 to 40 milligrams bambermycins per head per day. Each use of this free-choice Type C medicated feed must be the subject of an approved form FDA 1900 as required by 21 CFR 510.455. Daily bambermycins intakes in excess of 20 mg/head/day have not been shown to be more effective than 20 mg/head/day. Amount: 40 - 800 grams per ton Type B feed. Indications: For increased rate of weight gain. Limitations: Bambermycins liquid Type B feeds may be manufactured from dry bambermycins Type A articles. The expiration date for the liquid Type B feed is 8 weeks after date of manufacture. The expiration date for the dry Type C feed made from the liquid Type B feed is 1 week after date of manufacture. Liquid Type B feeds containing bambermycins may be used in the preparation of dry complete ration Type C feeds. |