Details for New Drug Application (NDA): 212967
✉ Email this page to a colleague
The generic ingredient in AMPHOTERICIN B is amphotericin b. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.
Summary for 212967
| Tradename: | AMPHOTERICIN B |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | amphotericin b |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212967
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMPHOTERICIN B | amphotericin b | INJECTABLE, LIPOSOMAL;INJECTION | 212967 | ANDA | Mylan Institutional LLC | 67457-926 | 67457-926-50 | 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-926-50) / 12.5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE, LIPOSOMAL;INJECTION | Strength | 50MG/VIAL | ||||
| Approval Date: | Jun 30, 2025 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
