Details for New Drug Application (NDA): 209675
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The generic ingredient in CLONIDINE HYDROCHLORIDE is chlorthalidone; clonidine hydrochloride. There are twenty-one drug master file entries for this compound. Additional details are available on the chlorthalidone; clonidine hydrochloride profile page.
Summary for 209675
Tradename: | CLONIDINE HYDROCHLORIDE |
Applicant: | Novast Labs |
Ingredient: | clonidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209675
Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 209675
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209675 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-247 | 50742-247-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-247-05) |
CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209675 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-247 | 50742-247-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-247-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.1MG | ||||
Approval Date: | Mar 5, 2019 | TE: | AB1 | RLD: | No |
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