Dutasteride

Product NDC
42543-139
11-digit product format
425430139
Labeler code
42543
Product ID
42543-139_d4ed117f-b677-4e6e-b679-550fcbddbe27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dutasteride
Dosage form
CAPSULE
Route
ORAL
Labeler
Vensun Pharmaceuticals, Inc.
Application
ANDA208227
Marketing category
ANDA
Marketing start
2018-06-29
Marketing end
0000-00-00
Substance
DUTASTERIDE
Active strength
1 mg/1
Pharmacologic classes
5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record