Quetiapine Fumarate

Product NDC
70518-2282
11-digit product format
705182282
Labeler code
70518
Product ID
70518-2282_9110ca9b-8e37-14b8-e053-2a95a90a0a97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
quetiapine fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA208947
Marketing category
ANDA
Marketing start
2019-08-26
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
400 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record