Amphotericin B Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
X-Gen Pharmaceuticals, Inc. (2011-11-22)
Oldest Current Product
1992-04-29
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\AMPHOTERICIN B
FDAOB
INJECTION\INJECTION\AMPHOTERICIN B\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AMPHOTERICIN B
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\AMPHOTERICIN B

product(s) by strength(s)

amphotericin b 5 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1398221055ANDAX-Gen Pharmaceuticals, Inc.1992-04-29AMPHOTERICIN BINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA063206a0a54943-9ce4-4f3e-b681-a1a9144c16ce

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA060517FUNGIZONETrueAPOTHECON INC DIV BRISTOL MYERS SQUIBBANDA060517_001
2ANDA062728AMPHOTERICIN BTrueABRAXIS PHARMACEUTICAL PRODUCTS1987-04-13ANDA062728_001
3ANDA063206AMPHOTERICIN BX GEN PHARMACEUTICALS INC1992-04-29ANDA063206_001
4ANDA064062AMPHOTERICIN BTrueTEVA PARENTERAL MEDICINES INC1995-03-31ANDA064062_001
5ANDA064141AMPHOTERICIN BTrueABBOTT LABORATORIES1996-12-23ANDA064141_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA060517_001discontinuedAMPHOTERICIN B (50MG/VIAL)INJECTIONFalseFUNGIZONE
2ANDA062728_001discontinuedAMPHOTERICIN B (50MG/VIAL)INJECTIONFalse1987-04-13AMPHOTERICIN B
3ANDA063206_001RXAMPHOTERICIN B (50MG/VIAL)INJECTIONTrue1992-04-29AMPHOTERICIN B
4ANDA064062_001discontinuedAMPHOTERICIN B (50MG/VIAL)INJECTIONFalse1995-03-31AMPHOTERICIN B
5ANDA064141_001discontinuedAMPHOTERICIN B (50MG/VIAL)INJECTIONFalse1996-12-23AMPHOTERICIN B

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1a0a54943-9ce4-4f3e-b681-a1a9144c16ce (view SPL)Amphotericin B for Injection USP Rx Only FOR INTRAMUSCULAR AND INTRAVENOUS USEprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2011-11-2210398221055

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII