Application 215429

Type
NDA
Sponsor
ALMATICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VENBYSI XRVENLAFAXINE BESYLATETABLET, EXTENDED RELEASE; ORAL112.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52427-632venlafaxinevenlafaxineAlmatica Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75237SUPPL 2023-08-22
75202SUPPL 2023-08-22
75201SUPPL 2023-08-22
73637ORIG 2023-03-01
73636ORIG 2023-03-01
71501ORIG2022-06-30
71500ORIG2022-06-30
71499ORIG2022-06-30
71498ORIG2022-06-30
71497ORIG2022-06-30
71496ORIG2022-06-30