Application 212024

Type
ANDA
Sponsor
SPECGX LLC

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
0406-2224Levorphanol TartrateLevorphanol TartrateSpecGx LLCANDACurrent
0406-2224Levorphanol TartrateLevorphanol TartrateSpecGx LLCANDACurrent
0406-2224Levorphanol TartrateLevorphanol TartrateSpecGx LLCANDACurrent
0406-2224Levorphanol TartrateLevorphanol TartrateSpecGx LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76451ORIG 2023-11-07