FDA.report

Application 074556

Type
ANDA
Sponsor
TEVA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ACYCLOVIRACYCLOVIRTABLET;ORAL200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**NoNo
002ACYCLOVIRACYCLOVIRTABLET;ORAL400MGNoNo
003ACYCLOVIRACYCLOVIRTABLET;ORAL800MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-8943AcyclovirAcyclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8947AcyclovirAcyclovirTeva Pharmaceuticals USA, Inc.ANDACurrent
10544-102AcyclovirAcyclovirBlenheim Pharmacal, Inc.ANDACurrent
10544-103AcyclovirAcyclovirBlenheim Pharmacal, Inc.ANDACurrent
12634-520AcyclovirAcyclovirApotheca Inc.ANDACurrent
33261-227AcyclovirAcyclovirAidarex Pharmaceuticals LLCANDACurrent
33261-491AcyclovirAcyclovirAidarex Pharmaceuticals LLCANDACurrent
42708-073AcyclovirAcyclovirQPharma IncANDACurrent
42708-073AcyclovirAcyclovirQPharma IncANDACurrent
52959-544AcyclovirAcyclovirH.J. Harkins Company Inc.ANDACurrent
53808-0821AcyclovirAcyclovirState of Florida DOH Central PharmacyANDACurrent
53808-0894AcyclovirAcyclovirState of Florida DOH Central PharmacyANDACurrent
55289-462AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-629AcyclovirAcyclovirPD-Rx Pharmaceuticals, Inc.ANDACurrent
58118-8943AcyclovirAcyclovirClinical Solutions WholesaleANDACurrent
58118-8943AcyclovirAcyclovirClinical Solutions WholesaleANDACurrent
63629-1677AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-6349AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-6349AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-6376AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
63629-6376AcyclovirAcyclovirBryant Ranch PrepackANDACurrent
66116-414AcyclovirAcyclovirMedVantx, Inc.ANDACurrent
67296-1054AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
67296-1054AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
67296-1219AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
67296-1219AcyclovirAcyclovirRedPharm Drug, Inc.ANDACurrent
70518-0065AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-0065AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-0065AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-0798AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent
70518-0798AcyclovirAcyclovirREMEDYREPACK INC.ANDACurrent

Documents

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