Quetiapine Fumarate

Product NDC
27808-186
11-digit product format
278080186
Labeler code
27808
Product ID
27808-186_d9f3913d-6b98-437f-b8c5-73a277a2638b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Quetiapine Fumarate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Tris Pharma Inc.
Application
ANDA202939
Marketing category
ANDA
Marketing start
2019-11-15
Marketing end
0000-00-00
Substance
QUETIAPINE FUMARATE
Active strength
150 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record