Quetiapine fumarate

Product NDC
70518-1935
11-digit product format
705181935
Labeler code
70518
Product ID
70518-1935_83767997-ee05-1229-e053-2991aa0a50a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204203
Marketing category
ANDA
Marketing start
2019-03-06
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