Details for New Drug Application (NDA): 063206
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The generic ingredient in AMPHOTERICIN B is amphotericin b. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the amphotericin b profile page.
Summary for 063206
Tradename: | AMPHOTERICIN B |
Applicant: | Xgen Pharms |
Ingredient: | amphotericin b |
Patents: | 0 |
Suppliers and Packaging for NDA: 063206
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AMPHOTERICIN B | amphotericin b | INJECTABLE;INJECTION | 063206 | ANDA | XGen Pharmaceuticals DJB, Inc. | 39822-1055 | 39822-1055-5 | 10 mL in 1 VIAL (39822-1055-5) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 50MG/VIAL | ||||
Approval Date: | Apr 29, 1992 | TE: | RLD: | No |
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