FDA.reportPublic FDA data

Application 075562

Type
ANDA
Sponsor
NEPHRON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IPRATROPIUM BROMIDEIPRATROPIUM BROMIDESOLUTION;INHALATION0.02%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0487-9801Ipratropium BromideIpratropium BromideNephron SC Inc.ANDACurrent
0487-9801Ipratropium BromideIpratropium BromideNephron Pharmaceuticals CorporationANDACurrent
50090-4185Ipratropium BromideIpratropium BromideA-S Medication SolutionsANDACurrent
55154-4351Ipratropium BromideIpratropium BromideCardinal HealthANDACurrent
55154-4351Ipratropium BromideIpratropium BromideCardinal HealthANDACurrent
55154-4351Ipratropium BromideIpratropium BromideCardinal Health 107, LLCANDACurrent
55154-4351Ipratropium BromideIpratropium BromideCardinal HealthANDACurrent
68788-0547Ipratropium BromideIpratropium BromidePreferred Pharmaceuticals, IncANDACurrent
70518-2874Ipratropium BromideIpratropium BromideREMEDYREPACK INC.ANDACurrent
70518-2874Ipratropium BromideIpratropium BromideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43004ORIG2005-07-22
30936ORIG2003-04-14