FDA.reportPublic FDA data

Application 202418

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LAMIVUDINE AND ZIDOVUDINELAMIVUDINE; ZIDOVUDINETABLET;ORAL150MG;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50436-0597Lamivudine and ZidovudineLamivudine and ZidovudineUnit Dose ServicesANDACurrent
55700-096Lamivudine and ZidovudineLamivudine and ZidovudineLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-061Lamivudine ZidovudineLamivudine ZidovudineDirect RxANDACurrent
63629-4872Lamivudine and ZidovudineLamivudine and ZidovudineBryant Ranch PrepackANDACurrent
63629-4872Lamivudine and ZidovudineLamivudine and ZidovudineBryant Ranch PrepackANDACurrent
63629-4872Lamivudine and ZidovudineLamivudine and ZidovudineBryant Ranch PrepackANDACurrent
65862-597Lamivudine and ZidovudineLamivudine and ZidovudineAurobindo Pharma LimitedANDACurrent
65862-597Lamivudine and ZidovudineLamivudine and ZidovudineAurobindo Pharma LimitedANDACurrent
65862-597Lamivudine and ZidovudineLamivudine and ZidovudineAurobindo Pharma LimitedANDACurrent
65862-597Lamivudine and ZidovudineLamivudine and ZidovudineAurobindo Pharma LimitedANDACurrent
68084-416Lamivudine and ZidovudineLamivudine and ZidovudineAmerican Health PackagingANDACurrent
68084-416Lamivudine and ZidovudineLamivudine and ZidovudineAmerican Health PackagingANDACurrent
68084-416Lamivudine and ZidovudineLamivudine and ZidovudineAmerican Health PackagingANDACurrent
68084-416Lamivudine and ZidovudineLamivudine and ZidovudineAmerican Health PackagingANDACurrent
68084-416Lamivudine and ZidovudineLamivudine and ZidovudineAmerican Health PackagingANDACurrent