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VIBRA-TABS (nda050533)- (EQ 100MG BASE)

DOXYCYCLINE HYCLATE PFIZER
EQ 100MG BASE
No No
Expired Expired
None None
None No
Doxycycline is indicated for the treatment of the following infections: • Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. • Respiratory tract infections caused by Mycoplasma pneumoniae. • Lymphogranuloma venereum caused by Chlamydia trachomatis. • Psittacosis (ornithosis) caused by Chlamydophila psittaci. • Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. • Inclusion conjunctivitis caused by Chlamydia trachomatis. • Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. • Nongonococcal urethritis caused by Ureaplasma urealyticum. • Relapsing fever due to Borrelia recurrentis. Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: • Chancroid caused by Haemophilus ducreyi. • Plague due to Yersinia pestis. • Tularemia due to Francisella tularensis. • Cholera caused by Vibrio cholerae. • Campylobacter fetus infections caused by Campylobacter fetus. • Brucellosis due to Brucella species (in conjunction with streptomycin). • Bartonellosis due to Bartonella bacilliformis. • Granuloma inguinale caused by Klebsiella granulomatis. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: • Escherichia coli. • Enterobacter aerogenes. • Shigella species. • Acinetobacter species. • Respiratory tract infections caused by Haemophilus influenzae. • Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: • Upper respiratory infections caused by Streptococcus pneumoniae. • Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: • Uncomplicated gonorrhea caused by Neisseria gonorrhoeae. • Syphilis caused by Treponema pallidum. • Yaws caused by Treponema pallidum subspecies pertenue. • Listeriosis due to Listeria monocytogenes. • Vincent’s infection caused by Fusobacterium fusiforme. • Actinomycosis caused by Actinomyces israelii. • Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains.
12 0 9
Total Other Developers None
Drugs with Suitability Yes
EQ 100MG BASE ** ** - - 8
NDA Sales Available Total Generic Sales Available
No 9
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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