FDA.reportPublic FDA data

Application 072637

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 4MG BASENoNo
002ALBUTEROL SULFATEALBUTEROL SULFATETABLET;ORALEQ 2MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51407-367albuterol sulfatealbuterol sulfateGolden State Medical SupplyANDACurrent
51407-367albuterol sulfatealbuterol sulfateGolden State Medical SupplyANDACurrent
51407-368albuterol sulfatealbuterol sulfateGolden State Medical SupplyANDACurrent
51407-368albuterol sulfatealbuterol sulfateGolden State Medical SupplyANDACurrent
53489-176albuterol sulfatealbuterol sulfateSun Pharmaceutical Industries, Inc.ANDACurrent
53489-177albuterol sulfatealbuterol sulfateSun Pharmaceutical Industries, Inc.ANDACurrent
63629-2638albuterol sulfatealbuterol sulfateBryant Ranch PrepackANDACurrent
63629-2638albuterol sulfatealbuterol sulfateBryant Ranch PrepackANDACurrent
63629-2736albuterol sulfatealbuterol sulfateBryant Ranch PrepackANDACurrent
68084-949albuterol sulfatealbuterol sulfateAmerican Health PackagingANDACurrent
68084-949albuterol sulfatealbuterol sulfateAmerican Health PackagingANDACurrent
68084-949Albuterol SulfateAlbuterol SulfateAmerican Health PackagingANDACurrent
68084-952albuterol sulfatealbuterol sulfateAmerican Health PackagingANDACurrent
68084-952albuterol sulfatealbuterol sulfateAmerican Health PackagingANDACurrent
68084-952albuterol sulfatealbuterol sulfateAmerican Health PackagingANDACurrent
68788-0177albuterol sulfatealbuterol sulfatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-0255albuterol sulfatealbuterol sulfatePreferred Pharmaceuticals, Inc.ANDACurrent