FDA.reportPublic FDA data

Application 209264

Type
ANDA
Sponsor
AILEX PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CROMOLYN SODIUMCROMOLYN SODIUMCONCENTRATE;ORAL100MG/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-2483CROMOLYN SODIUMCROMOLYN SODIUMBryant Ranch PrepackANDACurrent
63629-2483CROMOLYN SODIUMCROMOLYN SODIUMBryant Ranch PrepackANDACurrent
63629-2483CROMOLYN SODIUMCROMOLYN SODIUMBryant Ranch PrepackANDACurrent
63629-2485CROMOLYN SODIUMCROMOLYN SODIUMBryant Ranch PrepackANDACurrent
63629-2485CROMOLYN SODIUMCROMOLYN SODIUMBryant Ranch PrepackANDACurrent
63629-2485CROMOLYN SODIUMCROMOLYN SODIUMBryant Ranch PrepackANDACurrent
63629-2485CROMOLYN SODIUMCROMOLYN SODIUMBryant Ranch PrepackANDACurrent
69784-200CROMOLYN SODIUMCROMOLYN SODIUMWoodward Pharma Services LLCANDACurrent
69784-200CROMOLYN SODIUMCROMOLYN SODIUMWoodward Pharma Services LLCANDACurrent
69784-200CROMOLYN SODIUMCROMOLYN SODIUMWoodward Pharma Services LLCANDACurrent
69784-200CROMOLYN SODIUMCROMOLYN SODIUMWoodward Pharma Services LLCANDACurrent
69784-200CROMOLYN SODIUMCROMOLYN SODIUMWoodward Pharma Services LLCANDACurrent
70556-101CROMOLYN SODIUMCROMOLYN SODIUMAilex Pharmaceuticals, LLCANDACurrent
70556-101CROMOLYN SODIUMCROMOLYN SODIUMAilex Pharmaceuticals, LLCANDACurrent
70556-101CROMOLYN SODIUMCROMOLYN SODIUMAilex Pharmaceuticals, LLCANDACurrent
70556-102Cromolyn SodiumCromolyn SodiumAilex Pharmaceuticals, LLCANDACurrent
70556-102Cromolyn SodiumCromolyn SodiumAilex Pharmaceuticals, LLCANDACurrent
70556-102Cromolyn SodiumCromolyn SodiumAilex Pharmaceuticals, LLCANDACurrent
76204-025Cromolyn Sodium Oral Solution (Concentrate)Cromolyn Sodium Oral Solution (Concentrate)Ritedose Pharmaceuticals, LLCANDACurrent
76204-025Cromolyn Sodium Oral Solution (Concentrate)Cromolyn Sodium Oral Solution (Concentrate)Ritedose Pharmaceuticals, LLCANDACurrent
76204-025Cromolyn Sodium Oral Solution (Concentrate)Cromolyn Sodium Oral Solution (Concentrate)Ritedose Pharmaceuticals, LLCANDACurrent
76204-025Cromolyn Sodium Oral Solution (Concentrate)Cromolyn Sodium Oral Solution (Concentrate)Ritedose Pharmaceuticals, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50121ORIG2017-10-19