U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 050762
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TROVAN/ZITHROMAX COMPLIANCE PAK AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE EQ 1GM BASE,N/A;N/A,EQ 100MG BASE FOR SUSPENSION, TABLET;ORAL Discontinued None No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/18/1998 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50-762.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050762a_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050762.cfm

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/18/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/50-762.pdf
Back to Top