FDA.reportPublic FDA data

Application 064163

Type
ANDA
Sponsor
AKORN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENTAKGENTAMICIN SULFATESOLUTION/DROPS;OPHTHALMICEQ 0.3% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13985-603Gentamicin SulfateGentamicin SulfateMWIANDACurrent
13985-603Gentamicin SulfateGentamicin SulfateMWIANDACurrent
13985-603Gentamicin SulfateGentamicin SulfateMWIANDACurrent
17478-283Gentamicin SulfateGentamicin SulfateAkornANDACurrent
17478-283Gentamicin SulfateGentamicin SulfateAkorn, Inc.ANDACurrent
17478-283Gentamicin SulfateGentamicin SulfateAkorn, Inc.ANDACurrent
17478-826Gentamicin SulfateGentamicin SulfateAkorn, Inc.ANDACurrent
17478-826Gentamicin SulfateGentamicin SulfateAkornANDACurrent
17478-826Gentamicin SulfateGentamicin SulfateAkorn, Inc.ANDACurrent
50090-0568Gentamicin SulfateGentamicin SulfateA-S Medication SolutionsANDACurrent
52959-103GENTAMICIN SULFATEGENTAMICIN SULFATEH.J. Harkins Company, IncANDACurrent
53002-9290Gentamicin SulfateGentamicin SulfateRPK Pharmaceuticals, Inc.ANDACurrent
53002-9290Gentamicin SulfateGentamicin SulfateRPK Pharmaceuticals, Inc.ANDACurrent
53217-229Gentamicin SulfateGentamicin SulfateAidarex Pharmaceuticals LLCANDACurrent
61919-918Gentamicin SulfateGentamicin SulfateDIRECT RXANDACurrent
61919-918Gentamicin SulfateGentamicin SulfateDIRECT RXANDACurrent
63187-764Gentamicin SulfateGentamicin SulfateProficient Rx LPANDACurrent
63187-764Gentamicin SulfateGentamicin SulfateProficient Rx LPANDACurrent
66267-971Gentamicin SulfateGentamicin SulfateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-971Gentamicin SulfateGentamicin SulfateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-971Gentamicin SulfateGentamicin SulfateNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6342Gentamicin SulfateGentamicin SulfatePreferred Pharamcaeuticals Inc.ANDACurrent
68788-6342Gentamicin SulfateGentamicin SulfatePreferred Pharamcaeuticals Inc.ANDACurrent
68788-6342Gentamicin SulfateGentamicin SulfatePreferred Pharamcaeuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8353ORIG2001-10-12