Quetiapine Fumarate
- Product NDC
- 27808-189
- 11-digit product format
- 278080189
- Labeler code
- 27808
- Product ID
- 27808-189_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
- 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