FDA.reportPublic FDA data

Application 020140

Type
NDA
Sponsor
ACROTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FUSILEVLEVOLEUCOVORIN CALCIUMPOWDER;INTRAVENOUSEQ 50MG BASE/VIALYesYes
002FUSILEVLEVOLEUCOVORIN CALCIUMSOLUTION;INTRAVENOUSEQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003FUSILEVLEVOLEUCOVORIN CALCIUMSOLUTION;INTRAVENOUSEQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68152-101FusilevlevoleucovorinSpectrum Pharmaceuticals, Inc.NDACurrent
68152-102FusilevlevoleucovorinSpectrum Pharmaceuticals, Inc.NDACurrent
72893-009FusilevlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-009FusilevlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-009FusilevlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-009FusilevlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-013FusilevlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-013FusilevlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-013FusilevlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-013FusilevlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-014FusilevlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-014FusilevlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-014FusilevlevoleucovorinAcrotech Biopharma LLCNDACurrent
72893-014FusilevlevoleucovorinAcrotech Biopharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65330SUPPL2020-11-25
65326SUPPL2020-11-25
62129SUPPL2020-03-11
61866SUPPL2020-02-05
61554SUPPL2020-01-10
61540SUPPL2020-01-09
2061SUPPL2011-05-04
12247SUPPL2011-05-02
41153ORIG2010-03-11
24174ORIG2010-03-11
12246SUPPL2008-07-15
2060SUPPL2008-07-15
12245ORIG2008-03-13
2059ORIG2008-03-12