FDA.reportPublic FDA data

Application 062396

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATECAPSULE;ORALEQ 100MG BASENoNo
002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATECAPSULE;ORALEQ 50MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-3141Doxycycline HyclateDoxycycline HyclateWest-Ward Pharmaceuticals CorpANDACurrent
0143-3141Doxycycline HyclateDoxycycline HyclateWest-Ward Pharmaceuticals CorpANDACurrent
0143-3141Doxycycline HyclateDoxycycline HyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-3141Doxycycline HyclateDoxycycline HyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-3142Doxycycline HyclateDoxycycline HyclateWest-Ward Pharmaceuticals CorpANDACurrent
0143-3142Doxycycline HyclateDoxycycline HyclateWest-Ward Pharmaceuticals CorpANDACurrent
0143-3142Doxycycline HyclateDoxycycline HyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-3142Doxycycline HyclateDoxycycline HyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9802Doxycycline HyclateDoxycycline HyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9802Doxycycline HyclateDoxycycline HyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9803Doxycycline HyclateDoxycycline HyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9803Doxycycline HyclateDoxycycline HyclateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9803Doxycycline HyclateDoxycycline HyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9803Doxycycline HyclateDoxycycline HyclateHikma Pharmaceuticals USA Inc.ANDACurrent
0440-1481Doxycyclate HyclateDoxycycline HyclateLiberty Pharmaceuticals, Inc.ANDACurrent
0440-7481Doxycycline HyclateDoxycycline HyclateLiberty Pharmaceuticals, Inc.ANDACurrent
0904-0428Doxycycline HyclateDoxycycline HyclateMajor PharmaceuticalsANDACurrent
0904-0428Doxycycline HyclateDoxycycline HyclateMajor PharmaceuticalsANDACurrent
0904-0428Doxycycline HyclateDoxycycline HyclateMajor PharmaceuticalsANDACurrent
0904-0428Doxycycline HyclateDoxycycline HyclateMajor PharmaceuticalsANDACurrent
10544-095Doxycycline HyclateDoxycycline HyclateBlenheim Pharmacal, Inc.ANDACurrent
10544-169Doxycycline HyclateDoxycycline HyclateBlenheim Pharmacal, Inc.ANDACurrent
21695-044Doxycycline HyclateDoxycycline HyclateRebel Distributors CorpANDACurrent
33261-151Doxycycline HyclateDoxycycline HyclateAidarex Pharmaceuticals LLCANDACurrent
42254-426Doxycycline HyclateDoxycycline HyclateRebel Distributors CorpANDACurrent
43063-019Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-019Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-019Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-019Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-604Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-604Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-604Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-604Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-988Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-988Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-988Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-988Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-988Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-999Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-999Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-999Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-999Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43538-600Morgidoxdoxycycline hyclateMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-600Morgidoxdoxycycline hyclateMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-601Morgidoxdoxycycline hyclateMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-601Morgidoxdoxycycline hyclateMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-610Morgidoxdoxycycline hyclateMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-610Morgidoxdoxycycline hyclateMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-611Morgidoxdoxycycline hyclateMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-611Morgidoxdoxycycline hyclateMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-620Morgidoxdoxycycline hyclateMedimetriks Pharmaceuticals, Inc.ANDACurrent
43538-621Morgidoxdoxycycline hyclateMedimetriks Pharmaceuticals, Inc.ANDACurrent
50090-0026Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-0026Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-0026Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-0026Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-0026Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-5825Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-5825Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
51655-648Doxycycline HyclateDoxycycline HyclateNorthwind PharmaceuticalsANDACurrent
52959-055Doxycycline HyclateDoxycycline HyclateH.J. Harkins Company, Inc.ANDACurrent
53808-0239Doxycycline HyclateDoxycycline HyclateState of Florida DOH Central PharmacyANDACurrent
53808-0832Doxycycline HyclateDoxycycline HyclateState of Florida DOH Central PharmacyANDACurrent
55289-107Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-107Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-107Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-107Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-502Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-502Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-502Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-502Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-502Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-502Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
55700-732Doxycycline HyclateDoxycycline HyclateQuality Care Products, LLCANDACurrent
55700-732Doxycycline HyclateDoxycycline HyclateQuality Care Products, LLCANDACurrent
55700-732Doxycycline HyclateDoxycycline HyclateQuality Care Products, LLCANDACurrent
55700-732Doxycycline HyclateDoxycycline HyclateQuality Care Products, LLCANDACurrent
55700-732Doxycycline HyclateDoxycycline HyclateQuality Care Products, LLCANDACurrent
55700-732Doxycycline HyclateDoxycycline HyclateQuality Care Products, LLCANDACurrent
59115-123Doxycycline HyclateDoxycycline HyclateHikma PharmaceuticalANDACurrent