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Thursday, February 7, 2013

Actions Taken by FDA Center for Veterinary Medicine

http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/UCM337888.pdf?source=govdelivery 

 Actions Taken by FDA Center for Veterinary Medicine
The following corrections or additions to the list were published in the Federal Register in January 2013.
February, 2013 CVMGreenBookandAnimalDrug@fda.hhs.gov 1
Original Approvals
This section displays the original approval. To read the complete approval, please refer to 21 CFR Parts
500 and the related Federal Register notices.

ANADA Number:  200-485
Trade Name: Meloxicam Injection
Pioneer: Metacam®
Ingredients: Meloxicam
Sponsor: Accord Healthcare, Inc.
Approval Date: December 21, 2012
Status: Rx
Route: Dogs: Intravenous or subcutaneous
Cats: Subcutaneous
Species: Dogs and cats
Drug Form: Sterile solution
Concentration: 5 mg/mL
Indications: Dogs: Meloxicam Injection 5 mg/mL Solution for Injection is indicated for the
control of pain and inflammation associated with osteoarthritis.
Cats: For the control of postoperative pain and inflammation associated with
orthopedic surgery, ovariohysterectomy and castration when administered prior
to surgery.

21 CFR 522.1367 78 FR 5713-5715
ANADA Number:  200-491
Trade Name: Loxicom®
Pioneer: Metacam®
Ingredients: Meloxicam
Sponsor: Norbrook Laboratories, Ltd.
Approval Date: December 19, 2012
Status: Rx
Route: Intravenous or subcutaneous injection
Species: Dogs and cats
Drug Form: Solution for injection
Concentration: 5 mg/mL meloxicam solution
Indications: Loxicom® (meloxicam) 5 mg/mL Injectable sterile solution is indicated for the
control of pain and inflammation associated with osteoarthritis in dogs and for
the control of postoperative pain and inflammation associated with orthopedic
surgery, ovariohysterectomy and castration when administered prior to surgery
in cats.

21 CFR 522.1367 78 FR 5713-5715
ANADA Number:  200-496
Trade Name: AmproMed™ P for Poultry
Pioneer: Amprol®
Ingredients: Amprolium
Sponsor: Cross Vetpharm Group Ltd.
Approval Date: October 25, 2012
Status: OTC
Route: Oral
Species: Growing chickens, turkeys, and laying hens
Drug Form: Oral Solution
Concentration: 96 mg/mL (9.6%)
Indications: For the treatment of coccidiosis in growing chickens, turkeys, and laying hens

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