FDA.reportPublic FDA data

Application 074749

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATESYRUP;ORALEQ 2MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0740Albuterol SulfateAlbuterol SulfateATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0740Albuterol SulfateAlbuterol SulfateAtlantic Biologicals CorpsANDACurrent
17856-0740Albuterol SulfateAlbuterol SulfateAtlantic Biologicals CorpsANDACurrent
21695-350Albuterol SulfateAlbuterol SulfateRebel Distributors CorpANDACurrent
50383-740Albuterol SulfateAlbuterol SulfateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-740Albuterol SulfateAlbuterol SulfateAkornANDACurrent
50383-740Albuterol SulfateAlbuterol SulfateAkornANDACurrent
50383-740Albuterol SulfateAlbuterol SulfateHi-Tech Pharmacal Co., Inc.ANDACurrent
68258-8001Albuterol SulfateAlbuterol SulfateDispensing Solutions, Inc.ANDACurrent
68788-0825Albuterol SulfateAlbuterol SulfatePreferred Pharmaceuticals, incANDACurrent
68788-0825Albuterol SulfateAlbuterol SulfatePreferred Pharmaceuticals, incANDACurrent