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- Simvastatin SIMVASTATIN 20 mg/1 Zydus Lifesciences Limited
Simvastatin
- Simvastatin SIMVASTATIN 20 mg/1 NuCare Pharmaceuticals,Inc.
- Simvastatin SIMVASTATIN 20 mg/1 PD-Rx Pharmaceuticals, Inc.
- Simvastatin SIMVASTATIN 20 mg/1 Direct_Rx
- SIMVASTATIN SIMVASTATIN 20 mg/1 A-S Medication Solutions
- Simvastatin SIMVASTATIN 20 mg/1 Cardinal Health 107, LLC
- SIMVASTATIN SIMVASTATIN 20 mg/1 PD-Rx Pharmaceuticals, Inc.
- Simvastatin SIMVASTATIN 20 mg/1 Accord Healthcare, Inc.
- Simvastatin SIMVASTATIN 20 mg/1 REMEDYREPACK INC.
- Simvastatin SIMVASTATIN 20 mg/1 A-S Medication Solutions
- SIMVASTATIN SIMVASTATIN 20 mg/1 Direct Rx
- SIMVASTATIN SIMVASTATIN 20 mg/1 NuCare Pharmaceuticals,Inc.
- SIMVASTATIN SIMVASTATIN 20 mg/1 RPK Pharmaceuticals, Inc.
- SIMVASTATIN SIMVASTATIN 20 mg/1 St Marys Medical Park Pharmacy
- Simvastatin SIMVASTATIN 20 mg/1 Aphena Pharma Solutions - Tennessee, LLC
- Simvastatin SIMVASTATIN 20 mg/1 RPK Pharmaceuticals, Inc.
- Simvastatin SIMVASTATIN 20 mg/1 PD-Rx Pharmaceuticals, Inc.
- Simvastatin SIMVASTATIN 20 mg/1 Bryant Ranch Prepack
- Simvastatin SIMVASTATIN 20 mg/1 Hisun Pharmaceuticals USA, Inc.
- Simvastatin SIMVASTATIN 20 mg/1 NorthStar Rx LLC
- Simvastatin SIMVASTATIN 20 mg/1 Zydus Pharmaceuticals USA Inc.
- Simvastatin SIMVASTATIN 20 mg/1 Proficient Rx LP
- Simvastatin SIMVASTATIN 20 mg/1 A-S Medication Solutions
- SIMVASTATIN SIMVASTATIN 20 mg/1 Bryant Ranch Prepack
- SIMVASTATIN SIMVASTATIN 20 mg/1 NuCare Pharmaceuticals,Inc.
- Simvastatin SIMVASTATIN 20 mg/1 Aurobindo Pharma Limited
- ZOCOR SIMVASTATIN 20 mg/1 Organon LLC
- Simvastatin SIMVASTATIN 20 mg/1 Zydus Lifesciences Limited
- SIMVASTATIN SIMVASTATIN 20 mg/1 Preferred Pharmaceuticals, Inc.
- Simvastatin SIMVASTATIN 20 mg/1 Direct_Rx
- Simvastatin SIMVASTATIN 20 mg/1 Northwind Pharmaceuticals, LLC
- Simvastatin SIMVASTATIN 20 mg/1 Camber Pharmaceuticals, Inc.
- Simvastatin SIMVASTATIN 20 mg/1 Bryant Ranch Prepack
- Simvastatin SIMVASTATIN 20 mg/1 Direct_Rx
- Simvastatin SIMVASTATIN 20 mg/1 NorthStar Rx LLC
- ZOCOR SIMVASTATIN 20 mg/1 Organon LLC
- Simvastatin SIMVASTATIN 20 mg/1 A-S Medication Solutions
- Simvastatin SIMVASTATIN 20 mg/1 Cardinal Health 107, LLC
- Simvastatin SIMVASTATIN 20 mg/1 REMEDYREPACK INC.
- SIMVASTATIN SIMVASTATIN 20 mg/1 QPharma Inc
- Simvastatin SIMVASTATIN 20 mg/1 Bryant Ranch Prepack
- SIMVASTATIN SIMVASTATIN 20 mg/1 Northwind Pharmaceuticals, LLC
- Simvastatin SIMVASTATIN 20 mg/1 American Health Packaging
- Simvastatin SIMVASTATIN 20 mg/1 Quallent Pharmaceuticals Health LLC
- Simvastatin SIMVASTATIN 20 mg/1 Aurobindo Pharma Limited
- SIMVASTATIN SIMVASTATIN 20 mg/1 Proficient Rx LP
- Simvastatin SIMVASTATIN 20 mg/1 Legacy Pharmaceutical Packaging, LLC
- SIMVASTATIN SIMVASTATIN 20 mg/1 Northwind Pharmaceuticals, LLC
- SIMVASTATIN SIMVASTATIN 20 mg/1 ST. MARY'S MEDICAL PARK PHARMACY
- Simvastatin SIMVASTATIN 20 mg/1 Preferred Pharmaceuticals, Inc.
- Simvastatin SIMVASTATIN 20 mg/1 A-S Medication Solutions
- Simvastatin SIMVASTATIN 20 mg/1 Proficient Rx LP
- SIMVASTATIN SIMVASTATIN 20 mg/1 Bryant Ranch Prepack
- Simvastatin SIMVASTATIN 20 mg/1 A-S Medication Solutions
- Simvastatin SIMVASTATIN 20 mg/1 NuCare Pharmaceuticals,Inc.
- SIMVASTATIN SIMVASTATIN 20 mg/1 NCS HealthCare of KY, LLC dba Vangard Labs
- Simvastatin SIMVASTATIN 20 mg/1 QPharma Inc
- SIMVASTATIN SIMVASTATIN 20 mg/1 Lupin Pharmaceuticals, Inc.
- Simvastatin SIMVASTATIN 20 mg/1 NuCare Pharmaceuticals,Inc.
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
65841-067
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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