Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020615
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) INJECTABLE;INJECTION Prescription AP Yes Yes
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 X-GEN PHARMS INC
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

INJECTABLE;INJECTION; 5MG/10ML (0.5MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE;INJECTION Prescription No AP 200673 FRESENIUS KABI USA
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE;INJECTION Prescription No AP 200300 HIKMA FARMACEUTICA
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE;INJECTION Prescription No AP 203167 X-GEN PHARMS INC
CLONIDINE HYDROCHLORIDE CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE;INJECTION Prescription No AP 202601 ZYDUS PHARMS
DURACLON CLONIDINE HYDROCHLORIDE 5MG/10ML (0.5MG/ML) INJECTABLE;INJECTION Prescription Yes AP 020615 MYLAN INSTITUTIONAL

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