FDA.reportPublic FDA data

Application 205960

Type
ANDA
Sponsor
BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ASENAPINE MALEATEASENAPINE MALEATETABLET;SUBLINGUALEQ 2.5MG BASENoNo
002ASENAPINE MALEATEASENAPINE MALEATETABLET;SUBLINGUALEQ 10MG BASENoNo
003ASENAPINE MALEATEASENAPINE MALEATETABLET;SUBLINGUALEQ 5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51991-358AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-358AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-359AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-359AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-360AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-360AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-360AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-360AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-361AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-361AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-361AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-361AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-928AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-928AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-928AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-928AsenapineASENAPINE MALEATEBreckenridge Pharmaceutical, Inc.ANDACurrent
64330-625Asenapine MaleateAsenapine MaleateCentaur Pharmaceuticals Private LimitedANDACurrent
69539-057AsenapineASENAPINE MALEATEMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-057AsenapineASENAPINE MALEATEMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-058AsenapineASENAPINE MALEATEMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-059AsenapineASENAPINE MALEATEMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-059AsenapineASENAPINE MALEATEMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-059AsenapineASENAPINE MALEATEMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-060AsenapineASENAPINE MALEATEMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-245AsenapineASENAPINE MALEATEMSN LABORATORIES PRIVATE LIMITEDANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65852ORIG2021-01-07