Quetiapine fumarate

Product NDC
70518-1909
11-digit product format
705181909
Labeler code
70518
Product ID
70518-1909_b94444c6-1929-b99d-e053-2a95a90a4456
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203359
Marketing category
ANDA
Marketing start
2019-02-26
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
300 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record