Simvastatin

Product NDC
0904-5802
11-digit product format
009045802
Labeler code
0904
Product ID
0904-5802_7309e48c-6bd1-4535-94d2-f897a8585d0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Simvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077752
Marketing category
ANDA
Marketing start
2006-12-20
Marketing end
2019-04-25
Substance
SIMVASTATIN
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record