FDA.reportPublic FDA data

Application 078643

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-782Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRising Pharma Holdings, Inc.ANDACurrent
16571-783Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideRising Pharma Holdings, Inc.ANDACurrent
53808-0639Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideState of Florida DOH Central PharmacyANDACurrent
53808-0881Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideState of Florida DOH Central PharmacyANDACurrent
57237-190Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideCitron Pharma LLCANDACurrent
57237-191Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideCitron Pharma LLCANDACurrent
60760-536Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideSt Mary's Medical Park PharmacyANDACurrent
60760-536Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideSt Mary's Medical Park PharmacyANDACurrent
60760-889Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideSt Mary's Medical Park PharmacyANDACurrent
60760-889Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideSt Mary's Medical Park PharmacyANDACurrent
60760-889Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideSt Mary's Medical Park PharmacyANDACurrent
60760-889Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideSt Mary's Medical Park PharmacyANDACurrent
65862-190Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-190Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-190Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-191Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-191Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-191Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideAurobindo Pharma LimitedANDACurrent
68071-2659Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2659Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2673Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2673Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2790Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8167Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-8221Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70518-3474Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3474Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3474Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3474Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3474Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3474Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3474Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-3474Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideREMEDYREPACK INC.ANDACurrent
71205-678Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideProficient Rx LPANDACurrent
71335-2110Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent
71335-2156Cyclobenzaprine HydrochlorideCyclobenzaprine HydrochlorideBryant Ranch PrepackANDACurrent