FDA.reportPublic FDA data

Application 078949

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUDESONIDEBUDESONIDESPRAY, METERED;NASAL0.032MG/INHNoNo
002BUDESONIDEBUDESONIDESPRAY, METERED;NASAL0.032MG/SPRAYNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0048BudesonideBudesonideWalgreensANDACurrent
0363-0048BudesonideBudesonideWalgreensANDACurrent
0363-0048BudesonideBudesonideWalgreensANDACurrent
0363-0048BudesonideBudesonideWalgreensANDACurrent
0536-1112BudesonideBudesonideRugby LaboratoriesANDACurrent
0536-1112BudesonideBudesonideRugby LaboratoriesANDACurrent
0536-1112BudesonideBudesonideRugby LaboratoriesANDACurrent
0536-1112BudesonideBudesonideRugby LaboratoriesANDACurrent
0536-1112BudesonideBudesonideRugby LaboratoriesANDACurrent
11822-1700BudesonideBudesonideRite AidANDACurrent
11822-1700BudesonideBudesonideRite AidANDACurrent
11822-1700BudesonideBudesonideRite AidANDACurrent
11822-1700BudesonideBudesonideRite AidANDACurrent
11822-6000BudesonideBudesonideRite AidANDACurrent
21130-710BudesonideBudesonideSafewayANDACurrent
21130-710BudesonideBudesonideSafewayANDACurrent
21130-710BudesonideBudesonideSafewayANDACurrent
36800-113BudesonideBudesonideTopco Associates LLCANDACurrent
36800-113BudesonideBudesonideTopco Associates LLCANDACurrent
36800-113BudesonideBudesonideTopco Associates LLCANDACurrent
46122-389BudesonideBudesonideAmerisource BergenANDACurrent
46122-389BudesonideBudesonideAmerisource BergenANDACurrent
46122-389BudesonideBudesonideAmerisource BergenANDACurrent
46122-389BudesonideBudesonideAmerisource BergenANDACurrent
49035-703BudesonideBudesonideWalmartANDACurrent
49035-703BudesonideBudesonideWalmartANDACurrent
49035-703BudesonideBudesonideWalmartANDACurrent
60505-0839Budesonide NasalBudesonideApotex Corp.ANDACurrent
60505-0839Budesonide NasalBudesonideApotex Corp.ANDACurrent
60505-0839Budesonide NasalBudesonideApotex Corp.ANDACurrent
60505-6129BudesonideBudesonideApotex Corp.ANDACurrent
60505-6129BudesonideBudesonideApotex Corp.ANDACurrent
60505-6129BudesonideBudesonideApotex Corp.ANDACurrent
60505-6194BudesonideBudesonideApotex Corp.ANDACurrent
60505-6194BudesonideBudesonideApotex Corp.ANDACurrent
60505-6194BudesonideBudesonideApotex Corp.ANDACurrent
60505-6194BudesonideBudesonideApotex Corp.ANDACurrent
69842-001BudesonideBudesonideCVS PharmacyANDACurrent
69842-001BudesonideBudesonideCVS PharmacyANDACurrent
69842-001BudesonideBudesonideCVS PharmacyANDACurrent