FDA.reportPublic FDA data

Application 065095

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATETABLET;ORALEQ 100MG BASENoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-2112DoxycyclineDoxycycline hyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-2112DoxycyclineDoxycycline hyclateWest-Ward Pharmaceuticals CorpANDACurrent
0143-2112DoxycyclineDoxycycline hyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-2112DoxycyclineDoxycycline hyclateWest-Ward Pharmaceuticals CorpANDACurrent
0143-2112DoxycyclineDoxycycline hyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0440-7483DoxycyclineDoxycycline hyclateLiberty Pharmaceuticals, Inc.ANDACurrent
0904-0430DoxycyclineDoxycycline hyclateMajor PharmaceuticalsANDACurrent
0904-0430DoxycyclineDoxycycline hyclateMajor PharmaceuticalsANDACurrent
0904-0430DoxycyclineDoxycycline hyclateMajor PharmaceuticalsANDACurrent
0904-0430DoxycyclineDoxycycline hyclateMajor PharmaceuticalsANDACurrent
10544-073DoxycyclineDoxycycline hyclateBlenheim Pharmacal, Inc.ANDACurrent
11819-311Doxycycline HyclateDoxycycline hyclateHHS/Program Support Center/Supply Service CenterANDACurrent
21695-581DoxycyclineDoxycycline HyclateRebel Distributors Corp.ANDACurrent
33261-143DoxycyclineDoxycycline hyclateAidarex Pharmaceuticals LLCANDACurrent
42852-002Doxycycline HyclateDoxycycline HyclateApothecary Shop Wholesale Inc.ANDACurrent
50090-3218DoxycyclineDoxycycline hyclateA-S Medication SolutionsANDACurrent
55154-7128DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-7128DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-7128DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-7128DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-7128DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-7469DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-8079DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-8079DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55154-8079DoxycyclineDoxycycline hyclateCardinal HealthANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-866DoxycyclineDoxycycline hyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
60429-069DoxycyclineDoxycycline hyclateGolden State Medical Supply, Inc.ANDACurrent
60429-069DoxycyclineDoxycycline hyclateGolden State Medical Supply, Inc.ANDACurrent
60429-069DoxycyclineDoxycycline hyclateGolden State Medical Supply, Inc.ANDACurrent
60429-069DoxycyclineDoxycycline hyclateGolden State Medical Supply, Inc.ANDACurrent
60760-215DoxycyclineDoxycycline hyclateSt Marys Medical Park PharmacyANDACurrent
60760-215DoxycyclineDoxycycline hyclateSt Marys Medical Park PharmacyANDACurrent
60760-215DoxycyclineDoxycycline hyclateSt Marys Medical Park PharmacyANDACurrent
60760-215DoxycyclineDoxycycline hyclateSt Marys Medical Park PharmacyANDACurrent
61919-433DOXYCYCLINEDOXYCYCLINEDirectRXANDACurrent
61919-433DOXYCYCLINEDOXYCYCLINEDirectRXANDACurrent
62584-693DoxycyclineDoxycycline HyclateAmerican Health PackagingANDACurrent
62584-693DoxycyclineDoxycycline HyclateAmerican Health PackagingANDACurrent
62584-693DoxycyclineDoxycycline HyclateAmerican Health PackagingANDACurrent
62584-693DoxycyclineDoxycycline HyclateAmerican Health PackagingANDACurrent
68071-4110DoxycyclineDoxycycline hyclateNuCare Pharmaceuticals,Inc.ANDACurrent
68387-381DoxycyclineDoxycycline hyclateKeltman Pharmaceuticals Inc.ANDACurrent
68645-021DoxycyclineDoxycycline hyclateLegacy Pharmaceutical PackagingANDACurrent
70518-3039DoxycyclineDoxycycline hyclateREMEDYREPACK INC.ANDACurrent
70518-3039DoxycyclineDoxycycline hyclateREMEDYREPACK INC.ANDACurrent
70518-3039DoxycyclineDoxycycline hyclateREMEDYREPACK INC.ANDACurrent
70518-3039DoxycyclineDoxycycline hyclateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39415SUPPL2014-07-30
30652SUPPL2014-07-24