FDA.reportPublic FDA data

Application 022468

Type
NDA
Sponsor
ACROTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOLOTYNPRALATREXATESOLUTION;INTRAVENOUS20MG/ML (20MG/ML)YesNo
002FOLOTYNPRALATREXATESOLUTION;INTRAVENOUS40MG/2ML (20MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
48818-001FolotynpralatrexateAllos TherapeuticsNDACurrent
48818-001FolotynpralatrexateAcrotech Biopharma LLCNDACurrent
48818-001FolotynpralatrexateAllos TherapeuticsNDACurrent
65219-550PralatrexatePralatrexateFresenius Kabi USA, LLCNDA AUTHORIZED GENERICCurrent
65219-552PralatrexatePralatrexateFresenius Kabi USA, LLCNDA AUTHORIZED GENERICCurrent
72893-003FolotynpralatrexateAcrotech Biopharma IncNDACurrent
72893-003FolotynpralatrexateAcrotech Biopharma IncNDACurrent
72893-003FolotynpralatrexateAcrotech Biopharma LLCNDACurrent
72893-003FolotynpralatrexateAcrotech Biopharma LLCNDACurrent
72893-003FolotynpralatrexateAcrotech Biopharma IncNDACurrent
72893-003FolotynpralatrexateAcrotech Biopharma LLCNDACurrent
72893-005FolotynpralatrexateAcrotech Biopharma LLCNDACurrent
72893-005FolotynpralatrexateAcrotech Biopharma IncNDACurrent
72893-005FolotynpralatrexateAcrotech Biopharma LLCNDACurrent
72893-005FolotynpralatrexateAcrotech Biopharma IncNDACurrent
72893-005FolotynpralatrexateAcrotech Biopharma LLCNDACurrent
72893-005FolotynpralatrexateAcrotech Biopharma IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65005SUPPL2020-10-23
64960SUPPL2020-10-21
63137SUPPL2020-05-19
63041SUPPL2020-05-15
17621SUPPL2016-05-17
29762SUPPL2016-05-16
38746SUPPL2012-06-06
17620SUPPL2012-06-06
29761SUPPL2012-06-04
7437SUPPL2012-06-04
38745SUPPL2012-02-17
29760SUPPL2012-02-17
29759SUPPL2011-01-14
7436SUPPL2011-01-14
7435SUPPL2011-01-14
38744SUPPL2011-01-10
17619SUPPL2011-01-10
17618SUPPL2011-01-10
7434SUPPL2010-04-29
38743SUPPL2010-04-28
22029ORIG2009-11-23
29758ORIG2009-09-29
17617ORIG2009-09-25