Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078712
Company: FOSUN PHARMA
Company: FOSUN PHARMA
| 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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/11/2007 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/03/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/18/2018 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/24/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/26/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/26/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/04/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |