FDA.reportPublic FDA data

Application 077559

Type
ANDA
Sponsor
CIPLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATE AND IPRATROPIUM BROMIDEALBUTEROL SULFATE; IPRATROPIUM BROMIDESOLUTION;INHALATIONEQ 0.083% BASE;0.017%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69097-173Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol SulfateCipla USA Inc.ANDACurrent
69097-173Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol SulfateCipla USA Inc.ANDACurrent
70518-2351Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol SulfateREMEDYREPACK INC.ANDACurrent
70518-2351Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol SulfateREMEDYREPACK INC.ANDACurrent
70518-2351Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol SulfateREMEDYREPACK INC.ANDACurrent
70518-2627Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol SulfateREMEDYREPACK INC.ANDACurrent
70518-2627Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol SulfateREMEDYREPACK INC.ANDACurrent
70518-2627Ipratropium Bromide and Albuterol SulfateIpratropium Bromide and Albuterol SulfateREMEDYREPACK INC.ANDACurrent