FDA.reportPublic FDA data

Application 205656

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROCURONIUM BROMIDEROCURONIUM BROMIDEINJECTABLE;INJECTION50MG/5ML (10MG/ML)NoNo
002ROCURONIUM BROMIDEROCURONIUM BROMIDEINJECTABLE;INJECTION100MG/10ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-616Rocuronium Bromiderocuronium bromideAlvogen Inc.ANDACurrent
47781-616Rocuronium Bromiderocuronium bromideAlvogen Inc.ANDACurrent
47781-616Rocuronium Bromiderocuronium bromideAlvogen Inc.ANDACurrent
47781-617Rocuronium Bromiderocuronium bromideAlvogen Inc.ANDACurrent
47781-617Rocuronium Bromiderocuronium bromideAlvogen Inc.ANDACurrent
47781-617Rocuronium Bromiderocuronium bromideAlvogen Inc.ANDACurrent
68083-364Rocuronium BromideRocuronium BromideGland Pharma LimitedANDACurrent
68083-364Rocuronium BromideRocuronium BromideGland Pharma LimitedANDACurrent
68083-365Rocuronium BromideRocuronium BromideGland Pharma LimitedANDACurrent
68083-365Rocuronium BromideRocuronium BromideGland Pharma LimitedANDACurrent
70860-651Rocuronium Bromiderocuronium bromideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-651Rocuronium Bromiderocuronium bromideAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-651Rocuronium Bromiderocuronium bromideAthenex Pharmaceutical Division, LLC.ANDACurrent
71872-7211Rocuronium Bromiderocuronium bromideMedical Purchasing Solutions, LLCANDACurrent
72611-756Rocuronium Bromiderocuronium bromideAlmaject, Inc.ANDACurrent
72611-756Rocuronium Bromiderocuronium bromideAlmaject, Inc.ANDACurrent
72611-756Rocuronium Bromiderocuronium bromideAlmaject, Inc.ANDACurrent
72611-757Rocuronium Bromiderocuronium bromideAlmaject, Inc.ANDACurrent
72611-757Rocuronium Bromiderocuronium bromideAlmaject, Inc.ANDACurrent
72611-757Rocuronium Bromiderocuronium bromideAlmaject, Inc.ANDACurrent