FDA.reportPublic FDA data

Application 209959

Type
ANDA
Sponsor
CIPLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATEAEROSOL, METERED;INHALATIONEQ 0.09MG BASE/INHNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5179ALBUTEROL SULFATEalbuterol sulfateA-S Medication SolutionsANDACurrent
50090-5179ALBUTEROL SULFATEalbuterol sulfateA-S Medication SolutionsANDACurrent
60687-662Albuterol SulfateAlbuterol SulfateAmerican Health PackagingANDACurrent
69097-142ALBUTEROL SULFATEalbuterol sulfateCipla USA Inc.ANDACurrent
69097-142ALBUTEROL SULFATEalbuterol sulfateCipla USA Inc.ANDACurrent
69097-142ALBUTEROL SULFATEalbuterol sulfateCipla USA Inc.ANDACurrent
69097-142ALBUTEROL SULFATEalbuterol sulfateCipla USA Inc.ANDACurrent
69097-142ALBUTEROL SULFATEalbuterol sulfateCipla USA Inc.ANDACurrent
69097-142ALBUTEROL SULFATEalbuterol sulfateCipla USA Inc.ANDACurrent
69097-142ALBUTEROL SULFATEalbuterol sulfateCipla USA Inc.ANDACurrent
69097-142ALBUTEROL SULFATEalbuterol sulfateCipla USA Inc.ANDACurrent
72572-014ALBUTEROL SULFATEalbuterol sulfateCivica Inc.ANDACurrent
72572-014ALBUTEROL SULFATEalbuterol sulfateCivica Inc.ANDACurrent
72572-014ALBUTEROL SULFATEalbuterol sulfateCivica Inc.ANDACurrent
72572-014ALBUTEROL SULFATEalbuterol sulfateCivica Inc.ANDACurrent
72572-014ALBUTEROL SULFATEalbuterol sulfateCivica Inc.ANDACurrent
76282-679ALBUTEROL SULFATEalbuterol sulfateExelan Pharmaceuticals, Inc.ANDACurrent
76282-679ALBUTEROL SULFATEalbuterol sulfateExelan Pharmaceuticals, Inc.ANDACurrent
76282-679ALBUTEROL SULFATEalbuterol sulfateExelan Pharmaceuticals, Inc.ANDACurrent
76282-679ALBUTEROL SULFATEalbuterol sulfateExelan Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62990ORIG2020-05-14