FDA.reportPublic FDA data

Application 206880

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS500MG/100ML (5MG/ML)NoNo
002LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS1000MG/100ML (10MG/ML)NoNo
003LEVETIRACETAM IN SODIUM CHLORIDELEVETIRACETAMINJECTABLE;INTRAVENOUS1500MG/100ML (15MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-635LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-635LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-636LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-636LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-637LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-637LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-755LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-755LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-757LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-757LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-759LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
43598-759LevetiracetamLevetiracetam InjectionDr.Reddy's Laboratories IncANDACurrent
68083-152LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-152LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-152LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-153LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-153LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-153LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-154LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-154LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
68083-154LevetiracetamLevetiracetamGland Pharma LimitedANDACurrent
70860-602LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-602LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-602LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-602LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-603LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-603LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-603LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-603LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-604LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-604LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-604LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-604LevetiracetamLevetiracetamAthenex Pharmaceutical Division, LLC.ANDACurrent