FDA.reportPublic FDA data

Application 074880

Type
ANDA
Sponsor
NEPHRON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALBUTEROL SULFATEALBUTEROL SULFATESOLUTION;INHALATIONEQ 0.083% BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0487-9501Albuterol SulfateAlbuterol SulfateNephron Pharmaceuticals CorporationANDACurrent
0487-9501Albuterol SulfateAlbuterol SulfateNephron SC Inc.ANDACurrent
21695-332Albuterol SulfateAlbuterol SulfateRebel Distributors Corp.ANDACurrent
51662-1499ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1499ALBUTEROL SULFATEALBUTEROL SULFATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
55154-4359Albuterol SulfateAlbuterol SulfateCardinal Health 107, LLCANDACurrent
55154-4359Albuterol SulfateAlbuterol SulfateCardinal Health, Inc.ANDACurrent
63187-204Albuterol SulfateAlbuterol SulfateProficient Rx LPANDACurrent
63187-204Albuterol SulfateAlbuterol SulfateProficient Rx LPANDACurrent
63187-204Albuterol SulfateAlbuterol SulfateProficient Rx LPANDACurrent
63187-204Albuterol SulfateAlbuterol SulfateProficient Rx LPANDACurrent
66267-746Albuterol SulfateAlbuterol SulfateNucare Pharmaceuticals, Inc.ANDACurrent
66267-746Albuterol SulfateAlbuterol SulfateNucare Pharmaceuticals, Inc.ANDACurrent
68071-4048Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4048Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4543Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4543Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4543Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4754Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,InANDACurrent
68071-4754Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4754Albuterol SulfateAlbuterol SulfateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-0134Albuterol SulfateAlbuterol SulfatePreferred Pharmaceuticals, IncANDACurrent
68788-7702Albuterol SulfateAlbuterol SulfatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7702Albuterol SulfateAlbuterol SulfatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7702Albuterol SulfateAlbuterol SulfatePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2413Albuterol SulfateAlbuterol SulfateREMEDYREPACK INC.ANDACurrent
70518-2413Albuterol SulfateAlbuterol SulfateREMEDYREPACK INC.ANDACurrent
70518-2413Albuterol SulfateAlbuterol SulfateREMEDYREPACK INC.ANDACurrent
70518-2413Albuterol SulfateAlbuterol SulfateREMEDYREPACK INC.ANDACurrent
70518-2613Albuterol SulfateAlbuterol SulfateREMEDYREPACK INC.ANDACurrent
70518-2613Albuterol SulfateAlbuterol SulfateREMEDYREPACK INC.ANDACurrent
70518-2613Albuterol SulfateAlbuterol SulfateREMEDYREPACK INC.ANDACurrent
76420-087Albuterol SulfateAlbuterol SulfateAsclemed USA, Inc.ANDACurrent