FDA.reportPublic FDA data

Application 204168

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FETZIMALEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 20MG BASEYesNo
002FETZIMALEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 40MG BASEYesNo
003FETZIMALEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 80MG BASEYesNo
004FETZIMALEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORALEQ 120MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0456-2202FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2202FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2202FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2202FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan USA, Inc.NDACurrent
0456-2202FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2202FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2202FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2212FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2212FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2212FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2212FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2212FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2212FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan USA, Inc.NDACurrent
0456-2212FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2220FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2220FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan USA, Inc.NDACurrent
0456-2220FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2220FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2220FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2220FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2220FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2240FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan USA, Inc.NDACurrent
0456-2240FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2240FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2240FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2240FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2240FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2240FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2280FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2280FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2280FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2280FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2280FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent
0456-2280FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan USA, Inc.NDACurrent
0456-2280FetzimaLEVOMILNACIPRAN HYDROCHLORIDEAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78266SUPPL 2024-04-25
78228SUPPL 2024-04-24
78201SUPPL 2024-04-22
75242SUPPL 2023-08-22
75172SUPPL 2023-08-21
73891SUPPL 2023-03-28
73870SUPPL 2023-03-27
68770SUPPL2021-09-24
68769SUPPL2021-09-24
68725SUPPL2021-09-22
61055SUPPL2019-11-26
61048SUPPL2019-11-26
60304SUPPL2019-10-08
50895SUPPL2017-12-27
50807SUPPL2017-12-21
46743SUPPL2017-01-10
46690SUPPL2017-01-06
40362SUPPL2014-08-05
40363SUPPL2014-07-23
10304SUPPL2014-07-23
32523SUPPL2014-05-27
24461ORIG2014-03-14
22946ORIG2014-03-14
19533ORIG2013-07-30
10303ORIG2013-07-29