Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075685
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Discontinued | None | No | No |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 06/09/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75685ta.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/17/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/17/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/05/2012 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/08/2011 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Modified |
Label is not available on this site. |
||
| 05/10/2010 | SUPPL-8 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/22/2009 | SUPPL-7 | Labeling, REMS-Proposal |
Label is not available on this site. |
||
| 01/29/2009 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/14/2005 | SUPPL-1 | Labeling |
Label is not available on this site. |