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| CLONIDINE HYDROCHLORIDE | 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/02/1996 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020615ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/01/2016 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/12/2013 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/11/2013 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/28/2010 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020615s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020615s003ltr.pdf | |
04/24/2009 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020615s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020615s002ltr.pdf | |
04/27/1999 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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 |
DURACLON
INJECTABLE;INJECTION; 1MG/10ML (0.1MG/ML)
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200673 | FRESENIUS KABI USA |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 200300 | HIKMA FARMACEUTICA |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 203167 | XGEN PHARMS |
CLONIDINE HYDROCHLORIDE | CLONIDINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 202601 | ZYDUS PHARMS |
DURACLON | CLONIDINE HYDROCHLORIDE | 1MG/10ML (0.1MG/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 020615 | MYLAN INSTITUTIONAL |