FDA.reportPublic FDA data

Application 204824

Type
NDA
Sponsor
ANTARES PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS10MG/0.4ML (10MG/0.4ML)YesYes
002OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS15MG/0.4ML (15MG/0.4ML)YesYes
003OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS20MG/0.4ML (20MG/0.4ML)YesYes
004OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS25MG/0.4ML (25MG/0.4ML)YesYes
005OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS7.5MG/0.4ML (7.5MG/0.4ML)YesNo
006OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS12.5MG/0.4ML (12.5MG/0.4ML)YesYes
007OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS17.5MG/0.4ML (17.5MG/0.4ML)YesYes
008OTREXUPMETHOTREXATESOLUTION;SUBCUTANEOUS22.5MG/0.4ML (22.5MG/0.4ML)YesYes
009OTREXUP PFSMETHOTREXATESOLUTION;SUBCUTANEOUS10MG/0.4ML (10MG/0.4ML)YesNo
010OTREXUP PFSMETHOTREXATESOLUTION;SUBCUTANEOUS15MG/0.6ML (15MG/0.6ML)YesNo
011OTREXUP PFSMETHOTREXATESOLUTION;SUBCUTANEOUS17.5MG/0.7ML (17.5MG/0.7ML)YesNo
012OTREXUP PFSMETHOTREXATESOLUTION;SUBCUTANEOUS20MG/0.8ML (20MG/0.8ML)YesNo
013OTREXUP PFSMETHOTREXATESOLUTION;SUBCUTANEOUS22.5MG/0.9ML (22.5MG/0.9ML)YesNo
014OTREXUP PFSMETHOTREXATESOLUTION;SUBCUTANEOUS25MG/ML (25MG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54436-010OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-010OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-010OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-010OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-010OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-010OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-012OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-012OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-012OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-012OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-012OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-012OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-015OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-015OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-015OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-015OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-015OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-015OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-017OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-017OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-017OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-017OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-017OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-017OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-020OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-020OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-020OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-020OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-020OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-020OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-022OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-022OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-022OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-022OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-022OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-022OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-025OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-025OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-025OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-025OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-025OtrexupmethotrexateAntares Pharma, Inc.NDACurrent
54436-025OtrexupmethotrexateAntares Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61504SUPPL2020-01-02
61463SUPPL2019-12-27
59290ORIG2019-07-09
59289ORIG2019-07-09
59288ORIG2019-07-09
59136SUPPL2019-06-20
59129SUPPL2019-06-20
53062SUPPL2018-03-20
53044SUPPL2018-03-16
49087SUPPL2017-07-27
19606SUPPL2016-05-27
10402SUPPL2014-11-12
40426SUPPL2014-11-10
43480ORIG2014-02-03
19605ORIG2013-10-17
32597ORIG2013-10-16