FDA.reportPublic FDA data

Application 202880

Type
NDA
Sponsor
PERSION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOHYDRO ERHYDROCODONE BITARTRATECAPSULE, EXTENDED RELEASE;ORAL10MGYesYes
002ZOHYDRO ERHYDROCODONE BITARTRATECAPSULE, EXTENDED RELEASE;ORAL15MGYesNo
003ZOHYDRO ERHYDROCODONE BITARTRATECAPSULE, EXTENDED RELEASE;ORAL20MGYesNo
004ZOHYDRO ERHYDROCODONE BITARTRATECAPSULE, EXTENDED RELEASE;ORAL30MGYesNo
005ZOHYDRO ERHYDROCODONE BITARTRATECAPSULE, EXTENDED RELEASE;ORAL40MGYesNo
006ZOHYDRO ERHYDROCODONE BITARTRATECAPSULE, EXTENDED RELEASE;ORAL50MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43376-210Zohydrohydrocodone bitartrateZogenix, Inc.NDACurrent
43376-215Zohydrohydrocodone bitartrateZogenix, Inc.NDACurrent
43376-220Zohydrohydrocodone bitartrateZogenix, Inc.NDACurrent
43376-230Zohydrohydrocodone bitartrateZogenix, Inc.NDACurrent
43376-240Zohydrohydrocodone bitartrateZogenix, Inc.NDACurrent
43376-250Zohydrohydrocodone bitartrateZogenix, Inc.NDACurrent
43376-310Zohydrohydrocodone bitartrateZogenix, Inc.NDACurrent
43376-315Zohydrohydrocodone bitartrateZogenix, Inc.NDACurrent
43376-320Zohydrohydrocodone bitartrateZogenix, Inc.NDACurrent
43376-330Zohydrohydrocodone bitartrateZogenix, Inc.NDACurrent
43376-340Zohydrohydrocodone bitartrateZogenix, Inc.NDACurrent
43376-350Zohydrohydrocodone bitartrateZogenix, Inc.NDACurrent
65224-310ZOHYDRO ERHydrocodone BitartratePernix TherapeuticsNDACurrent
65224-310ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-310ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-310ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-310ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-315ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-315ZOHYDRO ERHydrocodone BitartratePernix TherapeuticsNDACurrent
65224-315ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-315ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-315ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-320ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-320ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-320ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-320ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-320ZOHYDRO ERHydrocodone BitartratePernix TherapeuticsNDACurrent
65224-330ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-330ZOHYDRO ERHydrocodone BitartratePernix TherapeuticsNDACurrent
65224-330ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-330ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-330ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-340ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-340ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-340ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-340ZOHYDRO ERHydrocodone BitartratePernix TherapeuticsNDACurrent
65224-340ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-350ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-350ZOHYDRO ERHydrocodone BitartratePernix TherapeuticsNDACurrent
65224-350ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-350ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-350ZOHYDRO ERHydrocodone BitartratePersion Pharmaceuticals LLCNDACurrent
65224-910Hydrocodone BitartrateHydrocodone BitartratePersion Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
65224-915Hydrocodone BitartrateHydrocodone BitartratePersion Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
65224-920Hydrocodone BitartrateHydrocodone BitartratePersion Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
65224-930Hydrocodone BitartrateHydrocodone BitartratePersion Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
65224-940Hydrocodone BitartrateHydrocodone BitartratePersion Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
65224-950Hydrocodone BitartrateHydrocodone BitartratePersion Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66647SUPPL2021-03-08
66646SUPPL2021-03-08
66578SUPPL2021-03-08
60419SUPPL2019-10-09
60418SUPPL2019-10-09
60377SUPPL2019-10-08
55722SUPPL2018-10-01
55721SUPPL2018-10-01
55559SUPPL2018-09-21
55558SUPPL2018-09-21
48585SUPPL2017-05-31
46442SUPPL2016-12-21
46441SUPPL2016-12-21
46321SUPPL2016-12-20
46320SUPPL2016-12-20
45449SUPPL2016-10-03
10127SUPPL2016-04-22
32331SUPPL2015-07-07
40232SUPPL2015-02-17
44871SUPPL2015-02-06
32330SUPPL2015-02-05
32329SUPPL2014-08-20
19395SUPPL2014-08-20
43417ORIG2014-04-14
24108ORIG2014-04-01
44870ORIG2013-11-15
19394ORIG2013-10-25
10126ORIG2013-10-25