FDA.reportPublic FDA data

Application 203584

Type
ANDA
Sponsor
HEC PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLARITHROMYCINCLARITHROMYCINTABLET;ORAL250MGNoNo
002CLARITHROMYCINCLARITHROMYCINTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1931ClarithromycinClarithromycinLannett Company, Inc.ANDACurrent
0527-1931ClarithromycinClarithromycinLannett Company, Inc.ANDACurrent
0527-1931ClarithromycinClarithromycinLannett Company, Inc.ANDACurrent
0527-1931ClarithromycinClarithromycinLannett Company, Inc.ANDACurrent
0527-1931ClarithromycinClarithromycinLannett Company, Inc.ANDACurrent
0527-1932ClarithromycinClarithromycinLannett Company, Inc.ANDACurrent
0527-1932ClarithromycinClarithromycinLannett Company, Inc.ANDACurrent
0527-1932ClarithromycinClarithromycinLannett Company, Inc.ANDACurrent
0527-1932ClarithromycinClarithromycinLannett Company, Inc.ANDACurrent
0527-1932ClarithromycinClarithromycinLannett Company, Inc.ANDACurrent
43063-752ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-752ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-752ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-752ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-752ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-752ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-752ClarithromycinClarithromycinPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2441ClarithromycinClarithromycinA-S Medication SolutionsANDACurrent
50090-2441ClarithromycinClarithromycinA-S Medication SolutionsANDACurrent
50090-2515ClarithromycinClarithromycinA-S Medication SolutionsANDACurrent
50090-2515ClarithromycinClarithromycinA-S Medication SolutionsANDACurrent
50090-2515ClarithromycinClarithromycinA-S Medication SolutionsANDACurrent
53002-7561ClarithromycinClarithromycinRPK Pharmaceuticals, Inc.ANDACurrent
55700-535ClarithromycinClarithromycinLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-435ClarithromycinClarithromycinAmerican Health PackagingANDACurrent
60687-435ClarithromycinClarithromycinAmerican Health PackagingANDACurrent
60687-435ClarithromycinClarithromycinAmerican Health PackagingANDACurrent
61919-643CLARITHROMYCINCLARITHROMYCINDirect_RxANDACurrent
61919-643CLARITHROMYCINCLARITHROMYCINDirect_RxANDACurrent
61919-643CLARITHROMYCINCLARITHROMYCINDirectRXANDACurrent
61919-643CLARITHROMYCINCLARITHROMYCINDirect_RxANDACurrent
63187-376ClarithromycinClarithromycinProficient Rx LPANDACurrent
63187-376ClarithromycinClarithromycinProficient Rx LPANDACurrent
63187-376ClarithromycinClarithromycinProficient Rx LPANDACurrent
63187-376ClarithromycinClarithromycinProficient Rx LPANDACurrent
63629-7832ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
63629-7832ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
63629-8222ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
63629-8222ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
67296-1360ClarithromycinClarithromycinRedPharm Drug, Inc.ANDACurrent
67296-1360ClarithromycinClarithromycinRedPharm Drug, Inc.ANDACurrent
67296-1360ClarithromycinClarithromycinRedPharm Drug, Inc.ANDACurrent
68071-3116ClarithromycinClarithromycinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3116ClarithromycinClarithromycinNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3116ClarithromycinClarithromycinNuCare Pharmaceuticals, Inc.ANDACurrent
68788-7125ClarithromycinClarithromycinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7125ClarithromycinClarithromycinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7125ClarithromycinClarithromycinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7125ClarithromycinClarithromycinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7125ClarithromycinClarithromycinPreferred Pharmaceuticals Inc.ANDACurrent
70518-1136ClarithromycinClarithromycinREMEDYREPACK INC.ANDACurrent
70518-1136ClarithromycinClarithromycinREMEDYREPACK INC.ANDACurrent
70518-1136ClarithromycinClarithromycinREMEDYREPACK INC.ANDACurrent
70934-507ClarithromycinClarithromycinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0795ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
71335-0795ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
71335-0795ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
71335-1567ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent
71335-1567ClarithromycinClarithromycinBryant Ranch PrepackANDACurrent