Details for New Drug Application (NDA): 091368
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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 091368
Tradename: | CLONIDINE HYDROCHLORIDE |
Applicant: | Alembic Pharms Ltd |
Ingredient: | clonidine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 091368
Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 091368
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | TABLET;ORAL | 091368 | ANDA | Alembic Pharmaceuticals Limited | 46708-306 | 46708-306-10 | 100 TABLET in 1 CARTON (46708-306-10) |
CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | TABLET;ORAL | 091368 | ANDA | Alembic Pharmaceuticals Limited | 46708-306 | 46708-306-30 | 30 TABLET in 1 BOTTLE (46708-306-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.1MG | ||||
Approval Date: | Dec 6, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.2MG | ||||
Approval Date: | Dec 6, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.3MG | ||||
Approval Date: | Dec 6, 2011 | TE: | AB | RLD: | No |
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