DYANAVEL XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Nextwave Pharmaceuticals, Inc. The primary component is Amphetamine.
| Product ID | 24478-108_29d90873-ef23-4ea7-ad07-036887a8740e |
| NDC | 24478-108 |
| Product Type | Human Prescription Drug |
| Proprietary Name | DYANAVEL XR |
| Generic Name | Amphetamine |
| Dosage Form | Tablet, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2021-11-04 |
| Marketing Category | NDA / |
| Application Number | NDA210526 |
| Labeler Name | NextWave Pharmaceuticals, Inc |
| Substance Name | AMPHETAMINE |
| Active Ingredient Strength | 10 mg/1 |
| Pharm Classes | Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-08-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 24478-102 | Dyanavel XR | amphetamine |
| 24478-106 | DYANAVEL XR | amphetamine |
| 24478-108 | DYANAVEL XR | amphetamine |
| 24478-109 | DYANAVEL XR | amphetamine |
| 24478-110 | DYANAVEL XR | amphetamine |
| 27808-102 | Dyanavel XR | amphetamine |
| 27808-106 | DYANAVEL XR | amphetamine |
| 27808-108 | DYANAVEL XR | amphetamine |
| 27808-109 | DYANAVEL XR | amphetamine |
| 27808-110 | DYANAVEL XR | amphetamine |
| 70165-003 | Adzenys ER | Amphetamine |
| 70165-005 | Adzenys XR-ODT | Amphetamine |
| 70165-010 | Adzenys XR-ODT | Amphetamine |
| 66993-360 | Amphetamine Extended-Release Oral Suspension | Amphetamine |
| 50742-652 | Amphetamine Sulfate | Amphetamine |
| 69238-1563 | Amphetamine Sulfate | Amphetamine |
| 69238-1564 | Amphetamine Sulfate | Amphetamine |
| 69452-227 | Amphetamine Sulfate | Amphetamine |
| 69452-228 | Amphetamine Sulfate | Amphetamine |