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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022331

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JENLOGA (CLONIDINE HYDROCHLORIDE)
0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLONIDINE HYDROCHLORIDE
Proprietary Name: JENLOGA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022331
Product Number: 001
Approval Date: Sep 30, 2009
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
JENLOGA (CLONIDINE HYDROCHLORIDE)
0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLONIDINE HYDROCHLORIDE
Proprietary Name: JENLOGA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N022331
Product Number: 002
Approval Date: May 25, 2010
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
KAPVAY (CLONIDINE HYDROCHLORIDE)
0.1MG
Marketing Status: Discontinued
Active Ingredient: CLONIDINE HYDROCHLORIDE
Proprietary Name: KAPVAY
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 0.1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022331
Product Number: 003
Approval Date: Sep 28, 2010
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
KAPVAY (CLONIDINE HYDROCHLORIDE)
0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLONIDINE HYDROCHLORIDE
Proprietary Name: KAPVAY
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 0.2MG **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: N022331
Product Number: 004
Approval Date: Sep 28, 2010
Applicant Holder Full Name: CONCORDIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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