FDA.reportPublic FDA data

Application 212040

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERTAPENEM SODIUMERTAPENEM SODIUMINJECTABLE;INTRAMUSCULAR, INTRAVENOUSEQ 1GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-889ERTAPENEM SODIUMErtapenemNorthStar RxLLCANDACurrent
16714-889ERTAPENEM SODIUMErtapenemNorthStar RxLLCANDACurrent
43598-901ERTAPENEM SODIUMErtapenemDr.ReddyANDACurrent
43598-901ERTAPENEM SODIUMErtapenemDr.ReddyANDACurrent
43598-901ERTAPENEM SODIUMErtapenemDr.ReddyANDACurrent
68083-351ErtapenamErtapenam SodiumGland Pharma LimitedANDACurrent
68083-351ErtapenemErtapenem SodiumGland Pharma LimitedANDACurrent
68083-351ErtapenemErtapenem SodiumGland Pharma LimitedANDACurrent
72266-159ErtapenamErtapenam SodiumFosun Pharma USA IncANDACurrent
72266-159ErtapenemErtapenem SodiumFosun Pharma USA IncANDACurrent
72266-159ErtapenemErtapenem SodiumFosun Pharma USA IncANDACurrent
72266-159ErtapenemErtapenem SodiumFosun Pharma USA IncANDACurrent
72266-159ErtapenemErtapenem SodiumFosun Pharma USA IncANDACurrent