Details for New Drug Application (NDA): 202601
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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 202601
Tradename: | CLONIDINE HYDROCHLORIDE |
Applicant: | Zydus Pharms |
Ingredient: | clonidine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 202601
Mechanism of Action | Adrenergic alpha2-Agonists |
Suppliers and Packaging for NDA: 202601
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | INJECTABLE;INJECTION | 202601 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-601 | 68382-601-07 | 1 VIAL in 1 CARTON (68382-601-07) / 10 mL in 1 VIAL |
CLONIDINE HYDROCHLORIDE | clonidine hydrochloride | INJECTABLE;INJECTION | 202601 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-602 | 68382-602-07 | 1 VIAL in 1 CARTON (68382-602-07) / 10 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/10ML (0.1MG/ML) | ||||
Approval Date: | Feb 20, 2014 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/10ML (0.5MG/ML) | ||||
Approval Date: | Feb 20, 2014 | TE: | AP | RLD: | No |
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