FDA.reportPublic FDA data

Application 211484

Type
ANDA
Sponsor
VIRTUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVORPHANOL TARTRATELEVORPHANOL TARTRATETABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69543-412Levorphanol TartrateLevorphanol TartrateVirtus Pharmaceuticals, LLCANDACurrent
69543-412Levorphanol TartrateLevorphanol TartrateVirtus Pharmaceuticals, LLCANDACurrent
69543-412Levorphanol TartrateLevorphanol TartrateVirtus Pharmaceuticals, LLCANDACurrent
69543-412Levorphanol TartrateLevorphanol TartrateVirtus Pharmaceuticals, LLCANDACurrent
69543-412Levorphanol TartrateLevorphanol TartrateVirtus Pharmaceuticals, LLCANDACurrent
69543-412Levorphanol TartrateLevorphanol TartrateVirtus Pharmaceuticals, LLCANDACurrent
69543-412Levorphanol TartrateLevorphanol TartrateVirtus Pharmaceuticals, LLCANDACurrent
69543-417Levorphanol TartrateLevorphanol TartrateVirtus Pharmaceuticals, LLCANDACurrent
69543-417Levorphanol TartrateLevorphanol TartrateVirtus Pharmaceuticals, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76432ORIG 2023-11-07
57263ORIG2019-01-18