Details for New Drug Application (NDA): 209285
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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 209285
Tradename: | CLONIDINE HYDROCHLORIDE |
Applicant: | Chartwell Rx |
Ingredient: | clonidine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209285
Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 209285
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209285 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-606 | 68180-606-07 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-606-07) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 0.1MG | ||||
Approval Date: | Oct 23, 2017 | TE: | AB1 | RLD: | No |
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