Details for New Drug Application (NDA): 022331
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The generic ingredient in KAPVAY is clonidine hydrochloride. There are twenty-two drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the clonidine hydrochloride profile page.
Summary for 022331
Tradename: | KAPVAY |
Applicant: | Concordia Pharms Inc |
Ingredient: | clonidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Sep 30, 2009 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | May 25, 2010 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.1MG | ||||
Approval Date: | Sep 28, 2010 | TE: | RLD: | Yes |
Expired US Patents for NDA 022331
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Concordia Pharms Inc | JENLOGA | clonidine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022331-001 | Sep 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Concordia Pharms Inc | KAPVAY | clonidine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022331-003 | Sep 28, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Concordia Pharms Inc | JENLOGA | clonidine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022331-002 | May 25, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Concordia Pharms Inc | KAPVAY | clonidine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022331-004 | Sep 28, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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