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Abbreviated New Drug Application (ANDA): 212514
Company: SPIL

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPHOTERICIN B AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL;INJECTION Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/14/2021 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212514Orig1s000ltr.pdf

AMPHOTERICIN B

INJECTABLE, LIPOSOMAL;INJECTION; 50MG/VIAL
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMBISOME AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL;INJECTION Prescription Yes AB 050740 ASTELLAS
AMPHOTERICIN B AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 215354 AVET LIFESCIENCES
AMPHOTERICIN B AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 214010 EUGIA PHARMA
AMPHOTERICIN B AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 212967 MYLAN LABS LTD
AMPHOTERICIN B AMPHOTERICIN B 50MG/VIAL INJECTABLE, LIPOSOMAL;INJECTION Prescription No AB 212514 SPIL
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