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FDA Drug information

Simvastatin

Read time: 1 mins
Marketing start date: 23 Nov 2024
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Summary of product characteristics


Effective Time

20221017

Version

12

Spl Product Data Elements

Simvastatin Simvastatin SIMVASTATIN SIMVASTATIN ANHYDROUS CITRIC ACID ANHYDROUS LACTOSE ASCORBIC ACID HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE WHITE OVAL ZA19 Simvastatin Simvastatin SIMVASTATIN SIMVASTATIN ANHYDROUS CITRIC ACID ANHYDROUS LACTOSE ASCORBIC ACID FERRIC OXIDE RED FERRIC OXIDE YELLOW HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE PINK OVAL ZA20 Simvastatin Simvastatin SIMVASTATIN SIMVASTATIN ANHYDROUS CITRIC ACID ANHYDROUS LACTOSE ASCORBIC ACID FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE BROWN OVAL ZA21 Simvastatin Simvastatin SIMVASTATIN SIMVASTATIN ANHYDROUS CITRIC ACID ANHYDROUS LACTOSE ASCORBIC ACID FERRIC OXIDE RED HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE PINK OVAL ZA22 Simvastatin Simvastatin SIMVASTATIN SIMVASTATIN ANHYDROUS CITRIC ACID ANHYDROUS LACTOSE ASCORBIC ACID HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE WHITE TO OFF-WHITE CAPSULE ZA23

Application Number

ANDA077837

Brand Name

Simvastatin

Generic Name

Simvastatin

Product Ndc

65841-066

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-065-16 in bottle of 90 tablets Simvastatin Tablets USP, 5 mg Rx only NDC 65841-066-16 in bottle of 90 tablets Simvastatin Tablets USP, 10 mg Rx only NDC 65841-067-16 in bottle of 90 tablets Simvastatin Tablets USP, 20 mg Rx only NDC 65841-068-16 in bottle of 90 tablets Simvastatin Tablets USP, 40 mg Rx only NDC 65841-069-16 in bottle of 90 tablets Simvastatin Tablets USP, 80 mg Rx only Simvastatin tablets 5 mg Simvastatin tablets 10 mg Simvastatin tablets 20 mg Simvastatin tablets 40 mg Simvastatin tablets 80 mg

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