Busulfan is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Celltrion Usa, Inc.. The primary component is Busulfan.
| Product ID | 72606-559_63ede55c-8326-4a52-a873-f46ce8427ae6 |
| NDC | 72606-559 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Busulfan |
| Generic Name | Busulfan |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2019-12-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA210931 |
| Labeler Name | CELLTRION USA, INC. |
| Substance Name | BUSULFAN |
| Active Ingredient Strength | 6 mg/mL |
| Pharm Classes | Alkylating Activity [MoA],Alkylating Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2019-12-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA210931 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-12-01 |
| Marketing Category | ANDA |
| Application Number | ANDA210931 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-12-01 |
| Ingredient | Strength |
|---|---|
| BUSULFAN | 6 mg/mL |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0409-1112 | BUSULFAN | BUSULFAN |
| 16729-351 | Busulfan | busulfan |
| 25021-241 | Busulfan | Busulfan |
| 45963-640 | Busulfan | Busulfan |
| 51817-170 | Busulfan | busulfan |
| 60505-6177 | Busulfan | busulfan |
| 65219-160 | Busulfan | Busulfan |
| 67457-893 | Busulfan | Busulfan |
| 70121-1244 | Busulfan | Busulfan |
| 70860-216 | Busulfan | busulfan |
| 71288-116 | Busulfan | Busulfan |
| 71288-158 | Busulfan | Busulfan |
| 72485-210 | Busulfan | Busulfan |
| 72606-559 | Busulfan | Busulfan |
| 59148-047 | BUSULFEX | busulfan |
| 59148-070 | BUSULFEX | busulfan |
| 69784-620 | MYLERAN | busulfan |
| 76388-713 | MYLERAN | busulfan |
| 0517-0920 | N/A | busulfan |