Dyanavel XR
- Product NDC
- 27808-102
- 11-digit product format
- 278080102
- Labeler code
- 27808
- Product ID
- 27808-102_cbdb96a8-cb0d-47a0-8066-731d39843001
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- amphetamine
- Dosage form
- SUSPENSION, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Tris Pharma Inc
- Application
- NDA208147
- Marketing category
- NDA
- Marketing start
- 2015-10-01
- Marketing end
- 2023-12-31
- Substance
- AMPHETAMINE
- Active strength
- 3 mg/mL
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 27808-102-01 | 27808010201 | 464 mL in 1 BOTTLE (27808-102-01) | 464 ml | 2015-10-01 | 0000-00-00 | No | No | Current |