FDA.report

Application 204446

Type
ANDA
Sponsor
ACP NIMBLE

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 50MG BASENoNo
002DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 75MG BASENoNo
003DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 100MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-0427DoxycyclineDoxycyclineG&W Laboratories, Inc.ANDACurrent
0713-0428DoxycyclineDoxycyclineG&W Laboratories, Inc.ANDACurrent
0713-0429DoxycyclineDoxycyclineG&W Laboratories, Inc.ANDACurrent
0713-0554DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0554DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0554DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0554DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0554DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0554DoxycyclineDoxycyclineG&W Laboratories, Inc.ANDACurrent
0713-0555DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0555DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0555DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0555DoxycyclineDoxycyclineG&W Laboratories, Inc.ANDACurrent
0713-0555DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0555DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0570DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0571DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
0713-0572DoxycyclineDoxycyclineCosette Pharmaceuticals, Inc.ANDACurrent
40032-790DoxycyclinedoxycyclineNovel Laboratories, Inc.ANDACurrent
40032-790DoxycyclinedoxycyclineNovel Laboratories, Inc.ANDACurrent
40032-791DoxycyclinedoxycyclineNovel Laboratories, Inc.ANDACurrent
40032-791DoxycyclinedoxycyclineNovel Laboratories, Inc.ANDACurrent
40032-792DoxycyclinedoxycyclineNovel Laboratories, Inc.ANDACurrent
40032-792DoxycyclinedoxycyclineNovel Laboratories, Inc.ANDACurrent
43063-681DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, InANDACurrent
43063-682DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, InANDACurrent
43063-886DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-886DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-886DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-886DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-886DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-985DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-985DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-985DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-985DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-985DoxycyclineDoxycyclinePD-Rx Pharmaceuticals, Inc.ANDACurrent
43386-790DoxycyclinedoxycyclineGAVIS Pharmaceuticals, LLCANDACurrent
43386-790DoxycyclinedoxycyclineLupin Pharmaceuticals,Inc.ANDACurrent
43386-791DoxycyclinedoxycyclineLupin Pharmaceuticals,Inc.ANDACurrent
43386-791DoxycyclinedoxycyclineGAVIS Pharmaceuticals, LLCANDACurrent
43386-792DoxycyclinedoxycyclineLupin Pharmaceuticals,Inc.ANDACurrent
43386-792DoxycyclinedoxycyclineGAVIS Pharmaceuticals, LLCANDACurrent
50090-2397DoxycyclineDoxycyclineA-S Medication SolutionsANDACurrent
50090-3443DoxycyclineDoxycyclineA-S Medication SolutionsANDACurrent
50090-5983DoxycyclineDoxycyclineA-S Medication SolutionsANDACurrent
53002-0670DoxycyclineDoxycyclineRPK Pharmaceuticals, Inc.ANDACurrent
53002-0670DoxycyclineDoxycyclineRPK Pharmaceuticals, Inc.ANDACurrent
53002-0672DoxycyclineDoxycyclineRPK Pharmaceuticals, Inc.ANDACurrent
54348-573DoxycyclineDOXYCYCLINEPharmPak, Inc.ANDACurrent
60760-431DoxycyclineDoxycyclineSt. Mary's Medical Park PharmacyANDACurrent
61919-276DOXYCYCLINEDOXYCYCLINEDIRECT RXANDACurrent
61919-276DOXYCYCLINEDOXYCYCLINEDIRECT RXANDACurrent
61919-276DOXYCYCLINEDOXYCYCLINEDIRECT RXANDACurrent
61919-276DOXYCYCLINEDOXYCYCLINEDIRECT RXANDACurrent
63187-936DoxycyclineDoxycyclineProficient Rx LPANDACurrent
63187-936DoxycyclineDoxycyclineProficient Rx LPANDACurrent
63629-7970DoxycyclineDoxycyclineBryant Ranch PrepackANDACurrent
63629-7970DoxycyclineDoxycyclineBryant Ranch PrepackANDACurrent
67296-1603DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
67296-1603DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
67296-1674DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
67296-1674DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
67296-1674DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
68071-2617DoxycyclineDoxycyclineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2617DoxycyclineDoxycyclineNuCare Pharmaceuticals,Inc.ANDACurrent
69668-431MondoxyneDoxycyclineOculus Innovative SciencesANDACurrent
69668-432MondoxyneDoxycyclineSonoma Pharmaceuticals, Inc.ANDACurrent
69668-433Mondoxyne NL 100mgDoxycyclineOculus Innovative SciencesANDACurrent
69668-452Mondoxyne NLDoxycyclineSonoma Pharmaceuticals, Inc.ANDACurrent
69668-452Mondoxyne NLDoxycyclineSonoma Pharmaceuticals, Inc.ANDACurrent
69668-453Mondoxyne NLDoxycyclineSonoma Pharmaceuticals, Inc.ANDACurrent
69668-453Mondoxyne NLDoxycyclineSonoma Pharmaceuticals, Inc.ANDACurrent
70934-178DoxycyclineDoxycyclineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-178DoxycyclineDoxycyclineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-178DoxycyclineDoxycyclineDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-135DoxycyclineDoxycyclineProficient Rx LPANDACurrent
71205-135DoxycyclineDoxycyclineProficient Rx LPANDACurrent
71205-135DoxycyclineDoxycyclineProficient Rx LPANDACurrent
71205-135DoxycyclineDoxycyclineProficient Rx LPANDACurrent
71205-135DoxycyclineDoxycyclineProficient Rx LPANDACurrent

Documents

DocumentSubmission typeDate
32562ORIG2015-06-02