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U.S. Department of Health and Human Services

Animal & Veterinary

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NADA 135-940 Antirobe Aquadrops - supplemental approval (November 16, 1989)

Approval Date: November 16, 1989

I. GENERAL INFORMATION:

NADA135-940
Sponsor:The Upjohn Co
Generic Name:Clindamycin hydrochloride oral liquid
Trade Name:Antirobe Aquadrops
Marketing Status: 
Effect of Supplement:This supplemental application provides for the following additional claims: Aerobic bacteria: for the treatment of dental infections caused by susceptible strains of Staphylococcus aure us. Anaerobic bacteria: for the treatment of soft tissue infections (deep wounds and abscesses), dental infections, and osteomyelitis caused by or associated with susceptible strains of Bacteroides fragilis, Bacteroides melaninogenicus, Fusobacterium necrophorumand Clostridium perfringens.

Specifications:
Each milliliter of solution contains the equivalent of 25 milligrams (mg) clindamycin as the hydrochloride salt.

Conditions of use:

Dogs

Amount:
Wounds, abscesses, and dental infections: 2.5 to 15 milligrams per pound of body weight every 12 hours for a maximum of 28 days. Osteomyelitis: 5.0 to 15 milligrams per pound of body weight every 12 hours for a minimum of 28 days.

Indications:
For the treatment of skin infections (wounds and abscesses) due to susceptible strains of coagulase-positive staphylococci (Staphylococcus aureus or S. intermedius), deep wounds and abscesses due to susceptible strains of Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium ecrophorum, and Clostridium perfringens, dental infections due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens, and osteomyelitis due to susceptible strains of S. aureus, B. fragilis, P. melaninogenicus, F. necrophorum, and C. perfringens.

Limitations:
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Cats

Amount:
5.0 to 15.0 milligrams per pound of body weight every 24 hours for a maximum of 14 days.

Indications:
For the treatment of skin infections (wounds and abscesses) due to susceptible strains of S. aureus, S. intermedius, Streptococcus species, deep wounds and abscesses due to susceptible strains of Clostridium perfringens and Bacteroides fragilis, and dental infections due to susceptible strains of S. aureus, S. intermedius, Streptococcus species, C. perfringens, and B. fragilis.

Limitations:
Federal law restricts this drug to use by or on the order of a licensed veterinarian.