Quetiapine Fumarate

Product NDC
48433-324
11-digit product format
484330324
Labeler code
48433
Product ID
48433-324_55c1bce9-9d05-4621-839d-a98b8d862692
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Safecor Health, LLC
Application
ANDA091388
Marketing category
ANDA
Marketing start
2014-09-30
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
25 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record