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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020615
Company: MYLAN INSTITUTIONAL

Products on NDA 020615

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CLONIDINE HYDROCHLORIDE	5MG/10ML (0.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020615

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.

Labels for NDA 020615

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

Therapeutic Equivalents for NDA 020615

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

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