Amphetamine Extended-Release Oral Suspension is a Oral Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Prasco Laboratories. The primary component is Amphetamine.
| Product ID | 66993-360_47b2c382-7bf4-4264-a567-e81ef6c68b7a |
| NDC | 66993-360 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Amphetamine Extended-Release Oral Suspension |
| Generic Name | Amphetamine |
| Dosage Form | Suspension, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2019-12-12 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA204325 |
| Labeler Name | Prasco Laboratories |
| Substance Name | AMPHETAMINE |
| Active Ingredient Strength | 1 mg/mL |
| Pharm Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2020-09-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | NDA AUTHORIZED GENERIC |
| Application Number | NDA204325 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-12-12 |
| Ingredient | Strength |
|---|---|
| AMPHETAMINE | 1.25 mg/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 66993-360 | Amphetamine Extended-Release Oral Suspension | Amphetamine |
| 70165-003 | Adzenys ER | Amphetamine |
| 70165-005 | Adzenys XR-ODT | Amphetamine |
| 70165-010 | Adzenys XR-ODT | 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 |
| 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 |