FDA.reportPublic FDA data

Application 207531

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINFOR SUSPENSION;ORALEQ 100MG BASE/5MLNoNo
002AZITHROMYCINAZITHROMYCINFOR SUSPENSION;ORALEQ 200MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24658-706AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSANDACurrent
24658-706AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSANDACurrent
24658-708AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSANDACurrent
24658-708AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSANDACurrent
42806-147AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-147AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-147AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-147AZITHROMYCINazithromycinEpic Pharma, LLCANDACurrent
42806-149AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-149AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-149AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-149AZITHROMYCINazithromycinEpic Pharma, LLCANDACurrent
42806-150AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-150AZITHROMYCINazithromycinEpic Pharma, LLCANDACurrent
42806-150AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-150AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-151AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-151AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-151AZITHROMYCINAZITHROMYCINEpic Pharma, LLCANDACurrent
42806-151AZITHROMYCINazithromycinEpic Pharma, LLCANDACurrent
50090-6296AZITHROMYCINazithromycinA-S Medication SolutionsANDACurrent
53002-2231AZITHROMYCINAZITHROMYCINRPK Pharmaceuticals, Inc.ANDACurrent
55700-731AZITHROMYCINAZITHROMYCINQuality Care Products LLCANDACurrent
55700-731AZITHROMYCINAZITHROMYCINQuality Care Products LLCANDACurrent
55700-731AZITHROMYCINAZITHROMYCINQuality Care Products LLCANDACurrent
55700-784AZITHROMYCINAZITHROMYCINQuality Care Products, LLCANDACurrent
55700-784AZITHROMYCINAZITHROMYCINQuality Care Products, LLCANDACurrent
68071-4773AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4773AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4773AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4773AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4795AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4795AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5035AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5035AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7549AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7549AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7549AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7549AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7636AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7636AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7636AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals Inc.ANDACurrent
71205-253AZITHROMYCINAZITHROMYCINProficient Rx LPANDACurrent
71205-253AZITHROMYCINAZITHROMYCINProficient Rx LPANDACurrent
71205-253AZITHROMYCINAZITHROMYCINProficient Rx LPANDACurrent
71205-253AZITHROMYCINAZITHROMYCINProficient Rx LPANDACurrent
71205-566AZITHROMYCINAZITHROMYCINProficient Rx LPANDACurrent
71205-566AZITHROMYCINAZITHROMYCINProficient Rx LPANDACurrent
72189-314AZITHROMYCINAZITHROMYCINDirectRxANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48647ORIG2017-06-06