FDA.reportPublic FDA data

Application 075702

Type
ANDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CROMOLYN SODIUMCROMOLYN SODIUMSPRAY, METERED;NASAL5.2MG/SPRAYNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-5532Cromolyn SodiumCromolyn SodiumMajor PharmaceuticalsANDACurrent
37205-223Cromolyn SodiumCromolyn SodiumCardinal HealthANDACurrent
52183-199NasalCromcromolyn sodiumPrestige Brands Holdings, Inc.ANDACurrent
52183-199NasalCromcromolyn sodiumPrestige Brands Holdings, Inc.ANDACurrent
52183-199NasalCromcromolyn sodiumPrestige Brands Holdings, Inc.ANDACurrent
52183-199NasalCromcromolyn sodiumPrestige Brands Holdings, Inc.ANDACurrent
52183-199NasalCromcromolyn sodiumPrestige Brands Holdings, Inc.ANDACurrent
52183-199NasalCromcromolyn sodiumPrestige Brands Holdings, Inc.ANDACurrent
57782-397Cromolyn SodiumCromolyn SodiumBausch & Lomb IncorporatedANDACurrent
57782-397Cromolyn SodiumCromolyn SodiumBausch & Lomb IncorporatedANDACurrent
57782-397Cromolyn SodiumCromolyn SodiumBausch & Lomb IncorporatedANDACurrent
57782-397Cromolyn SodiumCromolyn SodiumBausch & Lomb IncorporatedANDACurrent
59779-075Cromolyn SodiumCromolyn SodiumCVS PharmacyANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30991ORIG2001-07-03
22496ORIG2001-07-03
18419ORIG2001-07-03