Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020760
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TROVAN PRESERVATIVE FREE ALATROFLOXACIN MESYLATE EQ 200MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
TROVAN PRESERVATIVE FREE ALATROFLOXACIN MESYLATE EQ 300MG BASE/VIAL INJECTABLE;INJECTION 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
12/18/1997 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020760a.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/17/2000 SUPPL-6 Labeling

Label is not available on this site.

05/17/2000 SUPPL-5 Labeling

Label is not available on this site.

05/17/2000 SUPPL-4 Labeling

Label is not available on this site.

05/17/2000 SUPPL-3 Labeling

Label is not available on this site.

03/02/1999 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1998 SUPPL-1 Labeling

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English