Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090466
Company: ORCHID HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GEMIFLOXACIN MESYLATE GEMIFLOXACIN MESYLATE EQ 320MG BASE TABLET;ORAL Prescription AB 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
06/15/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/090466Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2017 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/17/2017 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

GEMIFLOXACIN MESYLATE

TABLET;ORAL; EQ 320MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FACTIVE GEMIFLOXACIN MESYLATE EQ 320MG BASE TABLET;ORAL Prescription Yes AB 021158 LG CHEM LTD
GEMIFLOXACIN MESYLATE GEMIFLOXACIN MESYLATE EQ 320MG BASE TABLET;ORAL Prescription No AB 090466 ORCHID HLTHCARE

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