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FDA Drug information

Entecavir

Read time: 1 mins
Marketing start date: 28 Dec 2024
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Summary of product characteristics


Effective Time

20220826

Version

5

Spl Product Data Elements

Entecavir Entecavir ENTECAVIR ENTECAVIR ANHYDROUS CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE ROUND 920 Entecavir Entecavir ENTECAVIR ENTECAVIR ANHYDROUS CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE LIGHT-PINK TO PINK ROUND 921

Application Number

ANDA206745

Brand Name

Entecavir

Generic Name

Entecavir

Product Ndc

70771-1019

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1019-3 Entecavir Tablets USP, 0.5 mg Rx Only 30 tablets NDC 70771-1020-3 Entecavir Tablets USP, 1 mg Rx Only 30 tablets Entecavir tablets Entecavir tablets

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