FDA.reportPublic FDA data

Application 208250

Type
ANDA
Sponsor
CSPC OUYI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZITHROMYCINAZITHROMYCINTABLET;ORALEQ 250MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4527Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4527Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4527Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4601Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4601Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4601Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4601Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4602Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50090-4602Azithromycin DihydrateAzithromycin DihydrateA-S Medication SolutionsANDACurrent
50268-074Azithromycin DihydrateAzithromycin DihydrateAvPAKANDACurrent
50268-074Azithromycin DihydrateAzithromycin DihydrateAvPAKANDACurrent
50268-074Azithromycin DihydrateAzithromycin DihydrateAvPAKANDACurrent
51224-022Azithromycin DihydrateAzithromycin DihydrateTAGI Pharma, Inc.ANDACurrent
51224-022Azithromycin DihydrateAzithromycin DihydrateTAGI Pharma, Inc.ANDACurrent
53002-3224Azithromycin DihydrateAzithromycin DihydrateRPK Pharmaceuticals, Inc.ANDACurrent
53002-4228Azithromycin DihydrateAzithromycin DihydrateRPK Pharmaceuticals, Inc.ANDACurrent
55700-859Azithromycin DihydrateAzithromycin DihydrateQuality Care Products, LLCANDACurrent
68071-2878Azithromycin DihydrateAzithromycin DihydrateNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8101Azithromycin DihydrateAzithromycin DihydratePreferred Pharmaceuticals Inc.ANDACurrent
68788-8101Azithromycin DihydrateAzithromycin DihydratePreferred Pharmaceuticals Inc.ANDACurrent
70518-3501Azithromycin DihydrateAzithromycin DihydrateREMEDYREPACK INC.ANDACurrent
71205-430Azithromycin DihydrateAzithromycin DihydrateProficient Rx LPANDACurrent
71205-430Azithromycin DihydrateAzithromycin DihydrateProficient Rx LPANDACurrent
71205-430Azithromycin DihydrateAzithromycin DihydrateProficient Rx LPANDACurrent
72189-089AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATEDIRECT RXANDACurrent
72189-089AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATEDIRECT RXANDACurrent
72789-081Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-081Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-081Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-081Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-081Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-170Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-170Azithromycin DihydrateAzithromycin DihydratePD-Rx Pharmaceuticals, Inc.ANDACurrent
76420-046Azithromycin DihydrateAzithromycin DihydrateAsclemed USA, Inc.ANDACurrent
80425-0218Azithromycin DihydrateAzithromycin DihydrateAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent