FDA.report

Application 062505

Type
ANDA
Sponsor
CHARTWELL LIFE SCI

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATETABLET;ORALEQ 100MG BASENoNo
002DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATETABLET;ORALEQ 50MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
11819-305Doxycycline HyclateDoxycycline HyclateHHS/Program Support Center/Supply Service CenterANDACurrent
11819-348Doxycycline HyclateDoxycycline HyclateHHS/Program Support Center/Supply Service CenterANDACurrent
43063-891Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-891Doxycycline HyclateDoxycycline HyclatePD-Rx Pharmaceuticals, Inc.ANDACurrent
47781-491Doxycycline HyclateDoxycycline HyclateAlvogen, Inc.ANDACurrent
47781-491Doxycycline HyclateDoxycycline HyclateAlvogen, Inc.ANDACurrent
50090-2377Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-2446Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-2446Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-2446Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-3037Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-3037Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-3859Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-3859Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-3859Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-3860Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-4981Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-4981Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-4981Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
50090-4981Doxycycline HyclateDoxycycline HyclateA-S Medication SolutionsANDACurrent
51407-298Doxycycline HyclateDoxycycline HyclateGolden State Medical SupplyANDACurrent
51407-298Doxycycline HyclateDoxycycline HyclateGolden State Medical SupplyANDACurrent
51407-298Doxycycline HyclateDoxycycline HyclateGolden State Medical Supply, Inc.ANDACurrent
51407-298Doxycycline HyclateDoxycycline HyclateGolden State Medical Supply, Inc.ANDACurrent
51407-298Doxycycline HyclateDoxycycline HyclateGolden State Medical Supply, Inc.ANDACurrent
53002-2710Doxycycline HyclateDoxycycline HyclateRPK Pharmaceuticals, Inc.ANDACurrent
53401-100Doxycycline HyclateDoxycycline HyclateAphena Pharma Solutions (Formerly TestPak)ANDACurrent
57237-105Doxycycline HyclateDoxycycline HyclateCitron Pharma LLCANDACurrent
60760-626Doxycycline HyclateDoxycycline HyclateSt. Mary's Medical Park PharmacyANDACurrent
60760-626Doxycycline HyclateDoxycycline HyclateSt. Mary's Medical Park PharmacyANDACurrent
61919-667DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEDIRECT RXANDACurrent
61919-667DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEDirect_RxANDACurrent
61919-667DOXYCYCLINE HYCLATEDOXYCYCLINE HYCLATEDirect_RxANDACurrent
62135-625Doxycycline HyclateDoxycycline HyclateChartwell RX LLCANDACurrent
62135-625Doxycycline HyclateDoxycycline HyclateChartwell RX LLCANDACurrent
62135-625Doxycycline HyclateDoxycycline HyclateChartwell RX LLCANDACurrent
62135-626Doxycycline HyclateDoxycycline HyclateChartwell RX LLCANDACurrent
62135-626Doxycycline HyclateDoxycycline HyclateChartwell RX LLCANDACurrent
62135-626Doxycycline HyclateDoxycycline HyclateChartwell RX LLCANDACurrent
62135-626Doxycycline HyclateDoxycycline HyclateChartwell RX LLCANDACurrent
62135-626Doxycycline HyclateDoxycycline HyclateChartwell RX LLCANDACurrent
62135-626Doxycycline HyclateDoxycycline HyclateChartwell RX LLCANDACurrent
63629-8262Doxycycline HyclateDoxycycline HyclateBryant Ranch PrepackANDACurrent
63629-8262Doxycycline HyclateDoxycycline HyclateBryant Ranch PrepackANDACurrent
66116-412Doxycycline HyclateDoxycycline HyclateMedVantx, Inc.ANDACurrent
66267-416Doxycycline HyclateDoxycycline HyclateNuCare Pharmaceuticals, Inc.ANDACurrent
66267-416Doxycycline HyclateDoxycycline HyclateNuCare Pharmaceuticals, Inc.ANDACurrent
67253-391Doxycycline HyclateDoxycycline HyclatePar PharmaceuticalANDACurrent
67405-550Doxycycline HyclateDoxycycline HyclateHarris Pharmaceutical, IncANDACurrent
67405-550Doxycycline HyclateDoxycycline HyclateHarris Pharmaceutical, IncANDACurrent
68071-3206doxycycline hyclatedoxycycline hyclateNuCare Pharmaceuticals, Inc.ANDACurrent
68071-5265Doxycycline HyclateDoxycycline HyclateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5265Doxycycline HyclateDoxycycline HyclateNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5265Doxycycline HyclateDoxycycline HyclateNuCare Pharmaceuticals,Inc.ANDACurrent
68645-020Doxycycline HyclateDoxycycline HyclateLegacy Pharmaceutical PackagingANDACurrent
68788-6441Doxycycline HyclateDoxycycline HyclatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7638Doxycycline HyclateDoxycycline HyclatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7638Doxycycline HyclateDoxycycline HyclatePreferred Pharmaceuticals Inc.ANDACurrent
68788-7638Doxycycline HyclateDoxycycline HyclatePreferred Pharmaceuticals Inc.ANDACurrent
68788-9292Doxycycline HyclateDoxycycline HyclatePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9767Doxycycline HyclateDoxycycline HyclatePreferred Pharmaceuticals Inc.ANDACurrent
68999-625Doxycycline HyclateDoxycycline HyclateChartwell Governmental & Specialty RX, LLCANDACurrent
68999-625Doxycycline HyclateDoxycycline HyclateChartwell Governmental & Specialty RX, LLCANDACurrent
68999-625Doxycycline HyclateDoxycycline HyclateChartwell Governmental & Specialty RX, LLCANDACurrent
68999-626Doxycycline HyclateDoxycycline HyclateChartwell Governmental & Specialty RX, LLCANDACurrent
68999-626Doxycycline HyclateDoxycycline HyclateChartwell Governmental & Specialty RX, LLCANDACurrent
68999-626Doxycycline HyclateDoxycycline HyclateChartwell Governmental & Specialty RX, LLCANDACurrent
69097-227doxycycline hyclatedoxycycline hyclateCipla USA, Inc.ANDACurrent
69235-320Doxycycline HyclateDoxycycline HyclateMHC Pharma, LLCANDACurrent
70518-2478Doxycycline HyclateDoxycycline HyclateREMEDYREPACK INC.ANDACurrent
70518-3135Doxycycline HyclateDoxycycline HyclateREMEDYREPACK INC.ANDACurrent
70518-3135Doxycycline HyclateDoxycycline HyclateREMEDYREPACK INC.ANDACurrent
70882-101Doxycycline HyclateDoxycycline HyclateCambridge Therapeutics Technologies, LLCANDACurrent
71205-697Doxycycline HyclateDoxycycline HyclateProficient Rx LPANDACurrent
71335-1686Doxycycline HyclateDoxycycline HyclateBryant Ranch PrepackANDACurrent
71335-1686Doxycycline HyclateDoxycycline HyclateBryant Ranch PrepackANDACurrent
71335-1686Doxycycline HyclateDoxycycline HyclateBryant Ranch PrepackANDACurrent
71335-1686Doxycycline HyclateDoxycycline HyclateBryant Ranch PrepackANDACurrent
71335-1686Doxycycline HyclateDoxycycline HyclateBryant Ranch PrepackANDACurrent
71610-117Doxycycline HyclateDoxycycline HyclateAphena Pharma Solutions - Tennessee, LLCANDACurrent