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AMPHOTEC (nda050729)- (50MG/VIAL,100MG/VIAL)

AMPHOTERICIN B ALKOPHARMA USA
50MG/VIAL,100MG/VIAL
No No
Expired Expired
None None
None No
Amphotericin B liposome for injection is indicated for the following: *Empirical therapy for presumed fungal infection in febrile, neutropenic patients. *Treatment of Cryptococcal Meningitis in HIV infected patients. *Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate. *Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites.
0 0 0
Total Other Developers None
Drugs with Suitability No
50MG/VIAL ** ** - - -
100MG/VIAL ** ** - - -
NDA Sales Available Total Generic Sales Available
No 0
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country

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