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- Simvastatin SIMVASTATIN 5 mg/1 Zydus Lifesciences Limited
Simvastatin
- Simvastatin SIMVASTATIN 5 mg/1 Quallent Pharmaceuticals Health LLC
- Simvastatin SIMVASTATIN 5 mg/1 Aurobindo Pharma Limited
- Simvastatin SIMVASTATIN 5 mg/1 Bryant Ranch Prepack
- Simvastatin SIMVASTATIN 5 mg/1 Bryant Ranch Prepack
- SIMVASTATIN SIMVASTATIN 5 mg/1 Lupin Pharmaceuticals, Inc.
- Simvastatin SIMVASTATIN 5 mg/1 Camber Pharmaceuticals, Inc.
- Simvastatin SIMVASTATIN 5 mg/1 Aurobindo Pharma Limited
- Simvastatin SIMVASTATIN 5 mg/1 NorthStar Rx LLC
- Simvastatin SIMVASTATIN 5 mg/1 Zydus Lifesciences Limited
- Simvastatin SIMVASTATIN 5 mg/1 REMEDYREPACK INC.
- Simvastatin SIMVASTATIN 5 mg/1 Accord Healthcare, Inc.
- Simvastatin SIMVASTATIN 5 mg/1 REMEDYREPACK INC.
- Simvastatin SIMVASTATIN 5 mg/1 NorthStar Rx LLC
- Simvastatin SIMVASTATIN 5 mg/1 Bryant Ranch Prepack
- Simvastatin SIMVASTATIN 5 mg/1 Proficient Rx LP
- Simvastatin SIMVASTATIN 5 mg/1 Zydus Pharmaceuticals USA Inc.
- Simvastatin SIMVASTATIN 5 mg/1 Bryant Ranch Prepack
- Simvastatin SIMVASTATIN 5 mg/1 A-S Medication Solutions
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
65841-065
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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