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FDA Product

Clonidine Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Clonidine Hydrochloride

59746-668

Regulatory Information

59746-668

ANDA210338

C73584

February 14, 2018

USA

These highlights do not include all the information needed to use CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for CLONIDINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. CLONIDINE HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1974

HUMAN PRESCRIPTION DRUG LABEL

3

Company Information

022490515

Active Ingredients

Clonidine Hydrochloride

Quantity: 0.1 mg in 1 1

Code: W76I6XXF06

Class Code: ACTIB

Silicon Dioxide

Code: ETJ7Z6XBU4

Class Code: IACT

Hydroxypropyl Cellulose (type L)

Code: UKE75GEA7F

Class Code: IACT

Hypromellose 2208 (15000 Mpa.s)

Code: Z78RG6M2N2

Class Code: IACT

Magnesium Stearate

Code: 70097M6I30

Class Code: IACT

Sodium Lauryl Sulfate

Code: 368GB5141J

Class Code: IACT

Cellulose, Microcrystalline

Code: OP1R32D61U

Class Code: IACT

Active Moieties

Clonidine

Code: MN3L5RMN02

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