MYLERAN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Woodward Pharma Services Llc. The primary component is Busulfan.
| Product ID | 69784-620_37912dc1-0d80-4738-a778-8b3d0df4bb70 |
| NDC | 69784-620 |
| Product Type | Human Prescription Drug |
| Proprietary Name | MYLERAN |
| Generic Name | Busulfan |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-06-30 |
| Marketing Category | NDA / |
| Application Number | NDA009386 |
| Labeler Name | Woodward Pharma Services LLC |
| Substance Name | BUSULFAN |
| Active Ingredient Strength | 2 mg/1 |
| Pharm Classes | Alkylating Activity [MoA], Alkylating Drug [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-06-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 69784-620 | MYLERAN | busulfan |
| 76388-713 | MYLERAN | busulfan |
| 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 |
| 0517-0920 | N/A | busulfan |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MYLERAN 71644161 0596271 Live/Registered |
BURROUGHS WELLCOME & CO.(U. S. A.) INC. 1953-03-25 |