FDA.reportPublic FDA data

Application 202039

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL30MGNoNo
002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0095Fexofenadine hydrochlorideFexofenadine hydrochlorideWalgreen COANDACurrent
0363-0095Fexofenadine hydrochlorideFexofenadine hydrochlorideWalgreen COANDACurrent
0363-0097Fexofenadine hydrochlorideFexofenadine hydrochlorideWalgreen COANDACurrent
0363-0097Fexofenadine hydrochlorideFexofenadine hydrochlorideWalgreen COANDACurrent
10202-229Fexofenadine hydrochlorideFexofenadine hydrochloride7-elevenANDACurrent
13107-066Fexofenadine hydrochlorideFexofenadine hydrochlorideAurolife Pharma, LLCANDACurrent
13107-067Fexofenadine hydrochlorideFexofenadine hydrochlorideAurolife Pharma, LLCANDACurrent
42291-296Fexofenadine hydrochlorideFexofenadine hydrochlorideAvKARE, Inc.ANDACurrent
42291-297Fexofenadine hydrochlorideFexofenadine hydrochlorideAvKARE, Inc.ANDACurrent
42291-297Fexofenadine hydrochlorideFexofenadine hydrochlorideAvKARE, Inc.ANDACurrent
42291-297Fexofenadine hydrochlorideFexofenadine hydrochlorideAvKAREANDACurrent
46122-387Fexofenadine hydrochlorideFexofenadine hydrochlorideAmerisource BergenANDACurrent
46122-387Fexofenadine hydrochlorideFexofenadine hydrochlorideAmerisource BergenANDACurrent
49035-995Fexofenadine hydrochlorideFexofenadine hydrochlorideWal-Mart Stores, IncANDACurrent
49035-995Fexofenadine hydrochlorideFexofenadine hydrochlorideWal-Mart Stores, IncANDACurrent
50268-315Fexofenadine hydrochlorideFexofenadine hydrochlorideAvPAKANDACurrent
50268-316Fexofenadine hydrochlorideFexofenadine hydrochlorideAvPAKANDACurrent
50268-317Fexofenadine hydrochlorideFexofenadine hydrochlorideAvPAKANDACurrent
53217-363Fexofenadine hydrochlorideFexofenadine hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
53943-021Fexofenadine hydrochlorideFexofenadine hydrochlorideDiscount Drug MartANDACurrent
53943-021Fexofenadine hydrochlorideFexofenadine hydrochlorideDiscount Drug MartANDACurrent
54257-001Fexofenadine hydrochlorideFexofenadine hydrochlorideMagno-Humphries Labs, Inc.ANDACurrent
54257-001Fexofenadine hydrochlorideFexofenadine hydrochlorideMagno-Humphries Labs, Inc.ANDACurrent
55315-355Fexofenadine hydrochlorideFexofenadine hydrochlorideFredsANDACurrent
55315-355Fexofenadine hydrochlorideFexofenadine hydrochlorideFred'sANDACurrent
58602-710Fexofenadine hydrochlorideFexofenadine hydrochlorideAurohealth LLCANDACurrent
58602-710Fexofenadine hydrochlorideFexofenadine hydrochlorideAurohealth LLCANDACurrent
58602-711Fexofenadine hydrochlorideFexofenadine hydrochlorideAurohealth LLCANDACurrent
58602-711Fexofenadine hydrochlorideFexofenadine hydrochlorideAurohealth LLCANDACurrent
60000-409Fexofenadine hydrochlorideFexofenadine hydrochlorideAhold U.S.A., IncANDACurrent
60000-409Fexofenadine hydrochlorideFexofenadine hydrochlorideAhold U.S.A., IncANDACurrent
62011-0314Fexofenadine hydrochlorideFexofenadine hydrochlorideMCKESSONANDACurrent
62011-0314Fexofenadine hydrochlorideFexofenadine hydrochlorideHealthmartANDACurrent
62011-0315Fexofenadine hydrochlorideFexofenadine hydrochlorideMCKESSONANDACurrent
62011-0315Fexofenadine hydrochlorideFexofenadine hydrochlorideHealthmartANDACurrent
68071-1896Fexofenadine hydrochlorideFexofenadine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1896Fexofenadine hydrochlorideFexofenadine hydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68196-976Fexofenadine hydrochlorideFexofenadine hydrochlorideSam's West IncANDACurrent
68196-976Fexofenadine hydrochlorideFexofenadine hydrochlorideSam's West IncANDACurrent
68788-6848Fexofenadine hydrochlorideFexofenadine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6848Fexofenadine hydrochlorideFexofenadine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6848Fexofenadine hydrochlorideFexofenadine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-1218Fexofenadine hydrochlorideFexofenadine hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1218Fexofenadine hydrochlorideFexofenadine hydrochlorideREMEDYREPACK INC.ANDACurrent
70677-0007Fexofenadine hydrochlorideFexofenadine hydrochlorideSunmarkANDACurrent
70677-0007Fexofenadine hydrochlorideFexofenadine hydrochlorideMCKESSONANDACurrent
70677-0008Fexofenadine hydrochlorideFexofenadine hydrochlorideSunmarkANDACurrent
70677-0008Fexofenadine hydrochlorideFexofenadine hydrochlorideMCKESSONANDACurrent
71335-0483Fexofenadine hydrochlorideFexofenadine hydrochlorideBryant Ranch PrepackANDACurrent
71335-0483Fexofenadine hydrochlorideFexofenadine hydrochlorideBryant Ranch PrepackANDACurrent
71610-292Fexofenadine hydrochlorideFexofenadine hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent