Drugs@FDA: FDA Approved Drug Products

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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

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