Orange Book product
GEMIFLOXACIN MESYLATE EQ 320MG BASE
Orange Book ANDA 090466 · ORBION PHARMACEUTICALS PRIVATE LTD · Discontinued
Key facts
| Proprietary name | GEMIFLOXACIN MESYLATE |
|---|---|
| Active ingredients | GEMIFLOXACIN MESYLATE |
| Strength | EQ 320MG BASE |
| Dosage form | TABLET |
| Route | ORAL |
| Application | ANDA090466 |
| Applicant holder | ORBION PHARMACEUTICALS PRIVATE LTD |
| Marketing status | Discontinued |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Jun 15, 2015 |
At a glance
- None Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.