Details for New Drug Application (NDA): 009386
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NDA 009386 describes MYLERAN, which is a drug marketed by Waylis Therap and is included in one NDA. It is available from two suppliers. Additional details are available on the MYLERAN profile page.
The generic ingredient in MYLERAN is busulfan. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the busulfan profile page.
The generic ingredient in MYLERAN is busulfan. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the busulfan profile page.
Summary for 009386
| Tradename: | MYLERAN |
| Applicant: | Waylis Therap |
| Ingredient: | busulfan |
| Patents: | 0 |
Pharmacology for NDA: 009386
| Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for 009386
Suppliers and Packaging for NDA: 009386
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYLERAN | busulfan | TABLET;ORAL | 009386 | NDA | Woodward Pharma Services LLC | 69784-620 | 69784-620-25 | 25 TABLET, FILM COATED in 1 BOTTLE (69784-620-25) |
| MYLERAN | busulfan | TABLET;ORAL | 009386 | NDA | Waylis Therapeutics LLC | 80725-620 | 80725-620-25 | 25 TABLET, FILM COATED in 1 BOTTLE (80725-620-25) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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