Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Alvogen Inc.. The primary component is Amphetamine Aspartate Monohydrate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate.
| Product ID | 47781-180_2a2c90b5-baac-d1de-34ee-4274f6312cd2 |
| NDC | 47781-180 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII |
| Generic Name | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 30 Mg,cll |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-07-28 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA207388 |
| Labeler Name | Alvogen Inc. |
| Substance Name | AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE |
| Active Ingredient Strength | 8 mg/1; mg/1; mg/1; mg/1 |
| Pharm Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
| Marketing Start Date | 2017-07-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA207388 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-07-28 |
| Marketing Category | ANDA |
| Application Number | ANDA207388 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-07-28 |
| Marketing End Date | 2017-07-29 |
| Marketing Category | ANDA |
| Application Number | ANDA207388 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-07-28 |
| Marketing End Date | 2017-07-29 |
| Ingredient | Strength |
|---|---|
| AMPHETAMINE ASPARTATE MONOHYDRATE | 7.5 mg/1 |
| SPL SET ID: | c907301d-e24d-9609-5529-fed14f94549f |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI | |
| UPC Code |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 47781-174 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 5 mg,Cll |
| 47781-175 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 7.5 mg,Cll |
| 47781-176 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 10 mg,Cll |
| 47781-177 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 12.5 mg,Cll |
| 47781-178 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 15 mg,Cll |
| 47781-179 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 20 mg,Cll |
| 47781-180 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets,CII | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets, 30 mg,Cll |