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FDA Drug information

Varenicline

Read time: 1 mins
Marketing start date: 26 Nov 2024
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Summary of product characteristics


Effective Time

20230519

Version

1

Spl Product Data Elements

Varenicline Varenicline VARENICLINE TARTRATE VARENICLINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE TITANIUM DIOXIDE TRIACETIN WHITE TO OFF-WHITE ZV1 Varenicline Varenicline VARENICLINE TARTRATE VARENICLINE ANHYDROUS DIBASIC CALCIUM PHOSPHATE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE TITANIUM DIOXIDE TRIACETIN FD&C BLUE NO. 1 ALUMINUM LAKE Light Blue to Blue ZV2

Application Number

ANDA216723

Brand Name

Varenicline

Generic Name

Varenicline

Product Ndc

70771-1773

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1773-6 Varenicline Tablets, 0.5 mg 56 Tablets Rx only NDC 70771-1774-6 Varenicline Tablets, 1 mg 56 Tablets Rx only 0.5 mg label 1 mg label

Drug section

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