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New Abbreviated Drug Approvals:
200-741
(Pioneer: 141-079)
Aurora Pharmaceutical, Inc.
EpriGard™ OTC
Calves, excluding veal calves
Cattle, beef, excluding veal calves
Cattle, dairy, all use classes
Meat Withdrawal: Zero
Milk Withdrawal: Zero
200-745
(Pioneer: 141-349)
Parnell Technologies Pty. Ltd.
RESPIRmycin™ 25
Calves, pre-ruminating
Swine
Meat Withdrawal: 22 days (beef)
Meat Withdrawal: 5 days (pork)
200-746
(Pioneer: 141-220)
Norbrook Laboratories Ltd.
Tauramox™ OTC
Calves, excluding veal calves
Cattle, beef, excluding veal calves
Cattle, dairy, not of breeding age
Meat Withdrawal: 21 days
March FDA changes in Marketing Status:
The FDA changed all species approvals from OTC to Rx for the following drugs. All shall bear the following warning: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
008-763 Terramycin® Ophthalmic Ointment with Polymyxin
012-965 Tylan® Injection 200 mg, Tylan® Injection 50 mg
031-715 ALBON (sulfadimethoxine) Boluses
031-944 Dynamyxin Injectable
034-025 LINCOMIX (lincomycin hydrochloride) Injectable Solution
037-586 Erythromast 36
041-245 Agribon Injection 40%, Albon®
041-629 Spectinomycin Oral Liquid
048-287 Oxytetracycline-50
055-039 Chlortetracycline Calf Oblets, 500 mg
055-072 Albadry Plus® Suspension
055-098 Albacillin® Suspension, Special Formula 17900-Forte® Suspension
065-010 NOROCILLIN (penicillin G procaine) Injectable Suspension
065-174 CRYSTICILLIN 300 A.S. Injectable Suspension
091-127 Rachelle Oxyvet Injection
092-523 GARASOL Solution
094-114 Liquamycin® 100, Terramycin® 100
097-222 TODAY Intramammary Infusion
099-402 Aquachel-100, Oxyvet-100
101-862 GARASOL Injection
103-037 GARACIN Injectable Solution
108-114 TOMORROW Intramammary Infusion
113-232 LIQUAMYCIN LA-200 Injectable Solution
122-271 SULMET (sulfamethazine) Oblets
138-955 TYLOVET Injectable Solution
140-582 BIOCYL–50 Injectable Solution; BIOCYL–100 Injectable Solution
141-143 NOROMYCIN 300 LA Injectable Solution
200-038 DI–METHOX (sulfadimethoxine) Injectable Solution
200-508 BILOVET (tylosin) Injectable Solution
200-523 SULFAMED (sulfadimethoxine) Injectable Solution
May FDA changes in Marketing Status:
The FDA changed all species approvals from OTC to Rx for the following drugs. All shall bear the following warning: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
012–123 GALLIMYCIN 100 Injection (erythromycin)
130–952 GENTOCIN Pinkeye Spray (gentamicin)
008–774 SULMET (sodium sulfamethazine) Injectable Solution
065–506 COMBI–PEN–48 (penicillin G benzathine and penicillin G procaine) Injectable Suspension
055–018 Chlortetracycline (chlortetracycline hydrochloride)
033–157 SPECTAM Scour-Halt (spectinomycin) Oral Solution
040–040 SPECTAM (spectinomycin) Injectable Solution
200–274 LINCOMIX (lincomycin hydrochloride)
200–368 Lincomycin Injectable, USP
035–456 GALLIMYCIN–36 (erythromycin) Intramammary Solution
200–315 LINCOMYCIN 300 (lincomycin hydrochloride) Injectable Solution
065–505 PRO–PEN–G (penicillin G procaine) Injectable Suspension
200–127 PROSPEC (spectinomycin hydrochloride) Injectable Solution
040–181 VETSULID (sulfachlorpyridazine) Oral Suspension
065–081 MASTI–CLEAR (penicillin G procaine) Suspension and GO–DRY (penicillin G procaine) Suspension
200–351 Lincomycin Injectable, USP
June FDA changes in Marketing Status:
The FDA changed all species approvals from OTC to Rx for the following drugs. All shall bear the following warning: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
011-060 Terramycin® Scour Tablets
035-455 Erythro®-36 Dry, Gallimycin®-36 Dry
045-143 Oxyject®
047-278 Bio-Mycin®, Oxy-Tet™ 50
055-097 Dry-Mast
065-004 Panmycin® 500 Bolus, Panmycin® Hydrochloride
065-110 PEN-G-MAX®
065-124 Tetracycline
065-270 Polyotic® Oblets®
065-383 Formula A-34, Uni Biotic 4 Dose
065-481 Calf Scour Boluses, Chlortetracycline Pneumonia
097-452 Oxyject® 100
108-963 Medamycin® Injectable
120-615 Sustain III® Bolus, Sustain III® Calf Bolus
140-270 SULFASURE SR / Sulfamethazine Sustained Release Bolus
141-909 Sulka-S™ Bolus
200-008 Bio-Mycin® 200 Injectable Solution, Oxy-Tet® 200 Injectable Solution
200-068 Oxytetracycline Hydrochloride Injection
200-117 Oxyshot® LA; Tetroxy® - LA
200-306 Oxytetracycline Injection 200
200-123 Maxim-200® Injection, Oxytetracycline Hydrochloride Injection 200mg
200-128 Agrimycin® - 200
200-147 Genta-Ject®, Gentamicin Sulfate Injection
200-154 Oxytetracycline 200, Pennox™ 200
200-174 Gentamicin Sulfate Pig Pump Oral Solution
200-364 Spectogard Scour-Chek™
200-394 Gentamicin Piglet Injection
200-452 Oxytet 100
200-468 GentaMed™-P for Poultry Injection
200-537 Tetroxy®-LA (formerly OxyMed™ LA)
Drugs voluntarily withdrawn:
The manufacturers' requested the FDA change the marketing status from "Approved" to "Withdrawn" because the following products are no longer manufactured or marketed.
141-527 BAYTRIL 100–CA1
011–532 SULFABROM (sulfabromomethazine sodium) Bolus
012–734 DIURIL (chlorothiazide) Bolus
013–022 THIBENZOLE (thiabendazole) Sheep & Goat Wormer
013–674 HYDROZIDE (hydrochlorothiazide) Injectable Solution
013–954 THIBENZOLE (thiabendazole) 20% Swine Premix
014–350 OMNIZOLE (thiabendazole) Oral Liquid
015–123 TBZ (thiabendazole) Cattle Wormer Oral Liquid
015–875 TBZ 200 (thiabendazole) Medicated Feed Premix
030–103 THIBENZOLE (thiabendazole) Oral Liquid
033–127 VETISULID (sulfachlorpyridazine) Bolus
033–318 VETISULID (sulfachlorpyridazine) Injectable Solution
034–114 EQUIZOLE (thiabendazole) Oral Liquid
035–631 THIBENZOLE (thiabendazole) Pig Wormer
043–141 THIBENZOLE 300 (thiabendazole) Medicated
048–487 TBZ (thiabendazole) Wormer Paste 50%
049–461 TBZ (thiabendazole) Wormer Paste 43%
095–642 OXY-TET (oxytetracycline hydrochloride) Injectable Solution
141-002 OXY 1000 Calf Bolus, OXY 500 Calf Bolus
200-191 Gentasol
Corrections:
034-266
Famix Famphur Premix
Dairy, non-lactating
Milk Withdrawal: 21 days
Limitations: Withdraw from dry dairy cows and heifers 21 days prior to freshening. (There is no value under Milk Withdrawal)
011-315
Neomix® 325 Soluble Powder, Neomix® AG 325 Soluble Powder
changed the class from Dairy, all uses classes to non-lactating Dairy
012-965
Tylan® Injection 200 mg, Tylan® Injection 50 mg
changed the class from Beef, all uses classes to Beef, excluding veal
141-064
Pulmotil® 90, Pulmotil® 90 Type A Medicated Article
changed Cattle, exl. veal to Cattle, fed in confinement for slaughter
141-450
Banamine Transdermal (flunixin transdermal solution)
changed Cattle, dairy, not of breeding age to Cattle, dairy, heifers
141-564
Pennchlor® and Rumensin™
changed the class Calves, excluding veal calves to Beef cattle, excluding veal calves
200-153
Neo 200 Oral Solution
changed the class from Dairy, all uses classes to Dairy, non-lactating
200-272
Noromectin® Pour-On for Cattle
changed the class from Dairy, all uses classes to Dairy, non-lactating
200-509
Tilmovet® 90
changed Cattle, exl. veal to Cattle, fed in confinement for slaughter
Removed approval for Calves, excluding veal calves:
006-417 Recovr Injectable
128-620 Panacur (Rx), Safe-Guard (OTC)
131-675 Safe-Guard® Type A Medicated Article
139-189 Safe-Guard® 20% Protein Block
140-269 Ketofen®
141-527 Baytril® 100-CA1
141-543 Draxxin® KP
200-162 Tripelennamine Hydrochloride Injection
Added approval for Calves, excluding veal calves:
128-409 Ivomec® 1% Injection for Cattle And Swine
141-064 Pulmotil® 90, Pulmotil® 90 Type A Medicated Article
200-219 Ivermectin Pour-On for Cattle, Phoenectin™ Pour-On for Cattle, Phoenectin®
200-228 Phoenectin™ Injection for Cattle and Swine
200-299 Iver-On™
200-318 Bimectin Pour-On
200-340 Privermectin™
200-348 Ecomectin
200-429 Ivermectin Injection
200-437 Noromectin®
200-447 Bimectin® Injection for Cattle and Swine
200-509 Tilmovet® 90
Added approval for Cattle, dairy, non-lactating:
200-046 Neomycin Soluble Powder 325g/lb, Neomycin Sulfate Soluble Powder, 325 g/lb
200-050 Neomed® 325 Soluble Powder
200-113 Biosol® Liquid
200-118 Neomycin Oral Solution
200-130 Neo-Sol 50®
200-235 Neosol Soluble Powder
200-289 Neosol-Oral
200-378 Neomycin Sulfate 325
200-379 Neomycin Liquid
Milk withdrawal times are always in hours:
128-620
Panacur® (Rx), Panacur® 10% Suspension (Rx), Safe-Guard® Suspension 10% (OTC)
Dairy, all use classes
Milk Withdrawal: 48 hours
131-675
Safe-Guard®, Safe-Guard® Dewormer 20% Type A Medicated Article, Safe-Guard® Type A Medicated Artic
Dairy, all use classes
Milk Withdrawal: 60 hours
132-872
Panacur® 10% Paste, Safe-Guard® 10% Paste
Dairy, all use classes
Milk Withdrawal: 96 hours
141-450
Banamine® Transdermal
Dairy, lactating
Milk Withdrawal: 48 hours