Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020615

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DURACLON (CLONIDINE HYDROCHLORIDE)
1MG/10ML (0.1MG/ML)
Marketing Status: Prescription

Active Ingredient: CLONIDINE HYDROCHLORIDE
Proprietary Name: DURACLON
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 1MG/10ML (0.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AP
Application Number: N020615
Product Number: 001
Approval Date: Oct 2, 1996
Applicant Holder Full Name: MYLAN INSTITUTIONAL LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

DURACLON (CLONIDINE HYDROCHLORIDE)
5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: CLONIDINE HYDROCHLORIDE
Proprietary Name: DURACLON
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/10ML (0.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020615
Product Number: 002
Approval Date: Apr 27, 1999
Applicant Holder Full Name: MYLAN INSTITUTIONAL LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information