Application Nr Approved Date Route Status External Links
ANDA207531 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Azithromycin For Oral Suspension Usp Is A Macrolide Antibacterial Drug Indicated For The Treatment Of Patients With Mild To Moderate Infections Caused By Susceptible Strains Of The Designated Microorganisms In The Specific Conditions Listed Below. Recommended Dosages And Durations Of Therapy In Adult And Pediatric Patient Populations Vary In These Indications. [See Dosage And Administration (2) ] Azithromycin For Oral Suspension Usp Is A Macrolide Antibacterial Drug Indicated For Mild To Moderate Infections Caused By Designated, Susceptible Bacteria: • Acute Bacterial Exacerbations Of Chronic Bronchitis In Adults ( 1.1 ) • Acute Bacterial Sinusitis In Adults ( 1.1 ) • Uncomplicated Skin And Skin Structure Infections In Adults ( 1.1 ) • Urethritis And Cervicitis In Adults ( 1.1 ) • Genital Ulcer Disease In Men ( 1.1 ) • Acute Otitis Media In Pediatric Patients ( 1.2 ) • Community-Acquired Pneumonia In Adults And Pediatric Patients ( 1.1 , 1.2 ) • Pharyngitis/tonsillitis In Adults And Pediatric Patients ( 1.1 , 1.2 ) Limitation Of Use : Azithromycin Should Not Be Used In Patients With Pneumonia Who Are Judged To Be Inappropriate For Oral Therapy Because Of Moderate To Severe Illness Or Risk Factors. ( 1.3 ) To Reduce The Development Of Drug-Resistant Bacteria And Maintain The Effectiveness Of Azithromycin For Oral Suspension Usp And Other Antibacterial Drugs, Azithromycin For Oral Suspension Usp Should Be Used Only To Treat Infections That Are Proven Or Strongly Suspected To Be Caused By Susceptible Bacteria. ( 1.4 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Azithromycin Monohydrate

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