FDA.reportPublic FDA data

Application 211890

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFEN AND FAMOTIDINEIBUPROFEN; FAMOTIDINETABLET;ORAL800MG; 26.6MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-8891Ibuprofen and famotidineIbuprofen and famotidineBryant Ranch PrepackANDACurrent
63629-8891Ibuprofen and famotidineIbuprofen and famotidineBryant Ranch PrepackANDACurrent
67877-626Ibuprofen and famotidineIbuprofen and famotidineAscend Laboratories, LLCANDACurrent
67877-626Ibuprofen and famotidineIbuprofen and famotidineAscend Laboratories, LLCANDACurrent
69306-266Ibuprofen and famotidineIbuprofen and famotidineDoc RxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68522ORIG2021-09-02