Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078183
Company: RISING
Company: RISING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN EXTENDED RELEASE | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 212.6MG;EQ 287.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
| CIPROFLOXACIN EXTENDED RELEASE | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 425.2MG;EQ 574.9MG BASE | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 03/22/2007 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/078183s000LTR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/03/2019 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2019 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2018 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2019 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/24/2017 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2016 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/18/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/14/2013 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/02/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/13/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/08/2011 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Modified, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/21/2009 | SUPPL-4 | Labeling, REMS-Proposal |
Label is not available on this site. |
||
| 12/02/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/28/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |