FDA.report

Application 065055

Type
ANDA
Sponsor
PAR PHARM

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 50MG BASENoNo
002DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 100MG BASENoNo
003DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 150MG BASENoYes
004DOXYCYCLINEDOXYCYCLINECAPSULE;ORALEQ 75MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
10337-815AdoxadoxycyclinePharmaDerm a division of Fougera Pharmaceuticals Inc.ANDACurrent
49884-305DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-305DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-305DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-305DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-726DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-726DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-726DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-726DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-727DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-727DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-727DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
49884-727DoxycyclinedoxycyclinePar Pharmaceutical, Inc.ANDACurrent
50090-1472DoxycyclinedoxycyclineA-S Medication SolutionsANDACurrent
50090-1472DoxycyclinedoxycyclineA-S Medication SolutionsANDACurrent
50090-1472DoxycyclinedoxycyclineA-S Medication SolutionsANDACurrent
51407-387DoxycyclinedoxycyclineGolden State Medical SupplyANDACurrent
51407-387DoxycyclinedoxycyclineGolden State Medical SupplyANDACurrent
51407-387DoxycyclinedoxycyclineGolden State Medical Supply, Inc.ANDACurrent
51407-387DoxycyclinedoxycyclineGolden State Medical Supply, Inc.ANDACurrent
51407-678DoxycyclinedoxycyclineGolden State Medical Supply, Inc.ANDACurrent
55700-323DoxycyclinedoxycyclineLake Erie Medical DBA Quality Care Products LLCANDACurrent
60687-716DoxycyclineDoxycyclineAmerican Health PackagingANDACurrent
63187-135DoxycyclinedoxycyclineProficient Rx LPANDACurrent
63187-135DoxycyclinedoxycyclineProficient Rx LPANDACurrent
63629-2183DoxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
63629-2183DoxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
63629-6637DoxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
63629-8212DoxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
63629-8212DoxycyclinedoxycyclineBryant Ranch PrepackANDACurrent
64380-179DoxycyclinedoxycyclineStrides Pharma Science LimitedANDACurrent
64380-180DoxycyclinedoxycyclineStrides Pharma Science LimitedANDACurrent
64380-181DoxycyclinedoxycyclineStrides Pharma Science LimitedANDACurrent
67296-1025DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
67296-1025DoxycyclineDoxycyclineRedPharm Drug, Inc.ANDACurrent
68084-743DoxycyclineDoxycyclineAmerican Health PackagingANDACurrent
68084-743DoxycyclineDoxycyclineAmerican Health PackagingANDACurrent
68084-743DoxycyclineDoxycyclineAmerican Health PackagingANDACurrent
68084-743DoxycyclineDoxycyclineAmerican Health PackagingANDACurrent
70518-0187DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0187DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0187DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0187DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0187DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0187DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0221DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
70518-0221DoxycyclinedoxycyclineREMEDYREPACK INC.ANDACurrent
76519-1206DOXYCYCLINEDOXYCYCLINEH.J. Harkins Company, Inc.ANDACurrent

Documents

DocumentSubmission typeDate
18325SUPPL2014-07-30
30641SUPPL2014-07-24
18324SUPPL2014-02-06
30640ORIG2000-12-01