Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020615
Company: MYLAN INSTITUTIONAL
Company: MYLAN INSTITUTIONAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DURACLON | CLONIDINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | AP | Yes | No |
| DURACLON | CLONIDINE HYDROCHLORIDE | 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/28/2010 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020615s003lbl.pdf | |
| 04/24/2009 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020615s002lbl.pdf |