FDA.reportPublic FDA data

Application 065246

Type
ANDA
Sponsor
PLIVA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-2026AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2026AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2026AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2026AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2027AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2027AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2027AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-2027AzithromycinAzithromycinTeva Pharmaceuticals USA, Inc.ANDACurrent
35356-199AzithromycinAzithromycinLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0983AzithromycinAzithromycinA-S Medication SolutionsANDACurrent
50090-0983AzithromycinAzithromycinA-S Medication SolutionsANDACurrent
50090-0984AzithromycinAzithromycinA-S Medication SolutionsANDACurrent
50090-0984AzithromycinAzithromycinA-S Medication SolutionsANDACurrent
53002-2230AzithromycinAzithromycinRPK Pharmaceuticals, Inc.ANDACurrent
55695-002AzithromycinAzithromycinDepartment of State Health Services, Pharmacy BranchANDACurrent
55695-002AzithromycinAzithromycinSTATE HEALTH SERVICES, TEXAS DEPARTMENT OFANDACurrent
55695-003AzithromycinAzithromycinDepartment of State Health Services, Pharmacy BranchANDACurrent
55695-003AzithromycinAzithromycinSTATE HEALTH SERVICES, TEXAS DEPARTMENT OFANDACurrent
61919-382AZITHROMYCINAZITHROMYCINDIRECT RXANDACurrent
63187-093AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-093AzithromycinAzithromycinProficient Rx LPANDACurrent
63187-093AzithromycinAzithromycinProficient Rx LPANDACurrent
68071-1527AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1527AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1527AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1528AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1528AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1605AzithromycinAzithromycinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9958AzithromycinAzithromycinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9958AzithromycinAzithromycinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9959AzithromycinAzithromycinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9959AzithromycinAzithromycinPreferred Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30657ORIG2006-07-13