Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050762
Company: PFIZER
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 |