Details for New Drug Application (NDA): 050729
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NDA 050729 describes AMPHOTEC, which is a drug marketed by Alkopharma Usa and is included in one NDA. Additional details are available on the AMPHOTEC profile page.
The generic ingredient in AMPHOTEC 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.
The generic ingredient in AMPHOTEC 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 050729
| Tradename: | AMPHOTEC |
| Applicant: | Alkopharma Usa |
| Ingredient: | amphotericin b |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050729
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE, LIPID COMPLEX;INJECTION | Strength | 50MG/VIAL | ||||
| Approval Date: | Nov 22, 1996 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE, LIPID COMPLEX;INJECTION | Strength | 100MG/VIAL | ||||
| Approval Date: | Nov 22, 1996 | TE: | RLD: | No | |||||
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