Application Nr Approved Date Route Status External Links
ANDA065425 2008-02-27 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Demeclocycline Hydrochloride Tablets And Other Antibacterial Drugs, Demeclocycline Hydrochloride Tablets Should Be Used Only To Treat Or Prevent Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. When Culture And Susceptibility Information Are Available, They Should Be Considered In Selecting Or Modifying Antibacterial Therapy. In The Absence Of Such Data, Local Epidemiology And Susceptibility Patterns May Contribute To The Empiric Selection Of Therapy. Demeclocycline Hydrochloride Is Indicated In The Treatment Of Infections Caused By Susceptible Strains Of The Designated Microorganisms In The Conditions Below: Rocky Mountain Spotted Fever, Typhus Fever And The Typhus Group, Q Fever, Rickettsialpox, And Tick Fevers Caused By Rickettsiae; Respiratory Tract Infections Caused By ; Lymphogranuloma Venereum Due To ; Psittacosis (ornithosis) Due To ; Trachoma Due To , Although The Infectious Agent Is Not Always Eliminated, As Judged By Immunofluorescence; Inclusion Conjunctivitis Caused By ; Nongonococcal Urethritis In Adults Caused By Or ; Relapsing Fever Due To ; Chancroid Caused By ; Plague Due To ; Tularemia Due To ; Cholera Caused By ; Campylobacter Fetus Infections Caused By ; Brucellosis Due To Species (in Conjunction With Streptomycin); Bartonellosis Due To ; Granuloma Inguinale Caused By ; Demeclocycline Hydrochloride Is Indicated For Treatment Of Infections Caused By The Following Gram-Negative Microorganisms, When Bacteriologic Testing Indicates Appropriate Susceptibility To The Drug: ; ; Species; Species; Respiratory Tract Infections Caused By ; Respiratory Tract And Urinary Tract Infections Caused By Species. Demeclocycline Hydrochloride 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 Pneumoniae; Skin And Skin Structure Infections Caused By . (note: Tetracyclines, Including Demeclocycline, Are Not The Drugs Of Choice In The Treatment Of Any Type Of Staphylococcal Infection.) When Penicillin Is Contraindicated, Tetracyclines, Including Demeclocycline Hydrochloride, Are Alternative Drugs In The Treatment Of The Following Infections: Uncomplicated Urethritis In Men Due To , And For The Treatment Of Other Uncomplicated Gonococcal Infections; Infections In Women Caused By ; Syphilis Caused By Subspecies ; Yaws Caused By Subspecies ; Listeriosis Due To ; Anthrax Due To ; Vincent’s Infection Caused By ; Actinomycosis Caused By ; Clostridial Diseases Caused By Species. In Acute Intestinal Amebiasis, Demeclocycline Hydrochloride May Be A Useful Adjunct To Amebicides. In Severe Acne, Demeclocycline Hydrochloride May Be A Useful Adjunctive Therapy. Mycoplasma Pneumoniae Chlamydia Trachomatis Chlamydia Psittaci Chlamydia Trachomatis Chlamydia Trachomatis Ureaplasma Urealyticum Chlamydia Trachomatis Borrelia Recurrentis Haemophilus Ducreyi Yersinia Pestis Francisella Tularensis Vibrio Cholerae Campylobacter Fetus Brucella Bartonella Bacilliformis Calymmatobacterium Granulomatis Escherichia Coli Enterobacter Aerogenes Shigella Acinetobacter Haemophilus Influenzae Klebsiella Streptococcus Staphylococcus Aureus Neisseria Gonorrhoeae Neisseria Gonorrhoeae Treponema Pallidum Pallidum Treponema Pallidum Pertenue Listeria Monocytogenes Bacillus Anthracis Fusobacterium Fusiforme Actinomyces Israelii Clostridium

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Alginic Acid ALGINIC ACID Unresolved GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Ethylcelluloses ETHYLCELLULOSES Unresolved
4. Hypromelloses HYPROMELLOSES Unresolved
5. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Demeclocycline Hydrochloride DEMECLOCYCLINE HYDROCHLORIDE ZINC100036924

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