LOVASTATIN- lovastatin tablet 
REMEDYREPACK INC.

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DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

ADVERSE REACTIONS

OVERDOSAGE

After oral administration of lovastatin to mice the median lethal dose observed was >15 g/m 2.

Until further experience is obtained, no specific treatment of overdosage with lovastatin can be recommended.

The dialyzability of lovastatin and its metabolites in man is not known at present

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

MM1

LOVASTATIN 
lovastatin tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:49349-986(NDC:61442-143)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOVASTATIN (UNII: 9LHU78OQFD) (LOVASTATIN - UNII:9LHU78OQFD) LOVASTATIN40 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (TABLET) Size10mm
FlavorImprint Code CTI;143
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49349-986-25240 in 1 CANISTER; Type 0: Not a Combination Product09/11/201210/23/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07599109/11/201210/23/2016
Labeler - REMEDYREPACK INC. (829572556)
Establishment
NameAddressID/FEIBusiness Operations
REMEDYREPACK INC.829572556repack(49349-986)

Revised: 10/2016
Document Id: 3dfd2c86-648b-640a-e054-00144ff8d46c
Set id: fe5c5d22-5299-4324-94ab-792e859acedb
Version: 3
Effective Time: 20161003
 
REMEDYREPACK INC.