FDA.reportPublic FDA data

Application 075824

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTORPHANOL TARTRATEBUTORPHANOL TARTRATESPRAY, METERED;NASAL1MG/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3090Butorphanol TartrateButorphanol TartrateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3090Butorphanol TartrateButorphanol TartrateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3090Butorphanol TartrateButorphanol TartrateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3090Butorphanol TartrateButorphanol TartrateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3090Butorphanol TartrateButorphanol TartrateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3090Butorphanol TartrateButorphanol TartrateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3090Butorphanol TartrateButorphanol TartrateHikma Pharmaceuticals USA Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76208ORIG 2023-11-03
22507ORIG2005-07-22
8797ORIG2003-04-10