FDA.reportPublic FDA data

Application 022370

Type
NDA
Sponsor
CIPHER PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CONZIPTRAMADOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL100MGYesYes
002CONZIPTRAMADOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL200MGYesNo
003CONZIPTRAMADOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL300MGYesNo
004CONZIPTRAMADOL HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL150MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13811-689Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-689Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-689Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED Current
13811-689Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-689Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-689Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-690Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-690Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-690Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-690Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-690Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-690Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED Current
13811-691Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED Current
13811-691Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-691Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-691Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-691Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
13811-691Tramadol Hydrochloridetramadol hydrochlorideTrigen Laboratories, LLCNDA AUTHORIZED GENERICCurrent
33261-880Tramadol HydrochlorideTramadol HydrochlorideAidarex Pharmaceuticals LLCNDACurrent
33261-960Tramadol HydrochlorideTramadol HydrochlorideAidarex Pharmaceuticals LLCNDACurrent
45865-709Tramadol HydrochlorideTramadol HydrochlorideMedsource PharmaceuticalsNDACurrent
45865-709Tramadol HydrochlorideTramadol HydrochlorideMedsource PharmaceuticalsNDACurrent
50436-0821Tramadol HydrochlorideTramadol HydrochlorideUnit Dose ServicesNDACurrent
53217-960Tramadol HydrochlorideTramadol HydrochlorideAidarex Pharmaceuticals LLCNDACurrent
55700-293Tramadol HydrochlorideTramadol HydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
55700-293Tramadol HydrochlorideTramadol HydrochlorideLake Erie Medical DBA Quality Care Products LLCNDACurrent
61919-002TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXNDACurrent
61919-583Tramadol HydrochlorideTramadol HydrochlorideDirect RxNDACurrent
63187-062Tramadol HydrochlorideTramadol HydrochlorideProficient Rx LPNDACurrent
63187-615Tramadol HydrochlorideTramadol HydrochlorideProficient Rx LPNDACurrent
63187-615Tramadol HydrochlorideTramadol HydrochlorideProficient Rx LPNDACurrent
63187-615Tramadol HydrochlorideTramadol HydrochlorideProficient Rx LPNDACurrent
63629-4900Tramadol HydrochlorideTramadol HydrochlorideBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-4900Tramadol HydrochlorideTramadol HydrochlorideBryant Ranch PrepackNDACurrent
68025-071ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-071ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-071ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-071ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-071ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-071ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-072ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-072ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-072ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-072ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-072ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-072ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-073ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-073ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-073ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-073ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-073ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68025-073ConZiptramadol hydrochlorideVertical Pharmaceuticals, LLCNDACurrent
68071-1978Tramadol HydrochlorideTramadol HydrochlorideNuCare Pharmaceuticals, Inc.NDACurrent
68071-1978Tramadol HydrochlorideTramadol HydrochlorideNuCare Pharmaceuticals, Inc.NDACurrent
68788-8920Tramadol HydrochlorideTramadol HydrochloridePreferred Pharmaceuticals Inc.NDACurrent
68788-8920Tramadol HydrochlorideTramadol HydrochloridePreferred PharmaceuticalsNDACurrent
69420-5150Tramadol HydrochlorideTramadol HydrochlorideSA3, LLCNDA AUTHORIZED GENERICCurrent
69420-5150Tramadol HydrochlorideTramadol HydrochlorideSA3, LLCNDA AUTHORIZED GENERICCurrent
69467-1001Tramadol HydrochlorideTramadol HydrochlorideSTA3, LLCNDA AUTHORIZED GENERICCurrent
69467-1001Tramadol HydrochlorideTramadol HydrochlorideSTA3, LLCNDA AUTHORIZED GENERICCurrent
69467-1001Tramadol HydrochlorideTramadol HydrochlorideSTA3, LLCNDA AUTHORIZED GENERICCurrent
69677-316Tramadol HydrochlorideTramadol HydrochlorideMas Management Group, Inc.NDACurrent
76519-1009Tramadol HydrochlorideTramadol HydrochlorideH.J. Harkins Company, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84655SUPPL 2026-01-06
84612SUPPL 2025-12-31
80076SUPPL 2024-11-04
77039SUPPL 2023-12-19
77033SUPPL 2023-12-19
76940SUPPL 2023-12-18
76238ORIG 2023-11-03
68613SUPPL2021-09-14
68604SUPPL2021-09-13
68603SUPPL2021-09-13
66641SUPPL2021-03-08
66640SUPPL2021-03-08
66560SUPPL2021-03-05
60389SUPPL2019-10-08
60387SUPPL2019-10-08
60369SUPPL2019-10-08
55691SUPPL2018-10-01
55690SUPPL2018-10-01
55598SUPPL2018-09-24
55597SUPPL2018-09-24
49641SUPPL2017-08-31
49603SUPPL2017-08-30
46343SUPPL2016-12-21
46342SUPPL2016-12-21
46338SUPPL2016-12-21
46337SUPPL2016-12-21
22007ORIG2011-02-22
38631ORIG2010-05-17
7303ORIG2010-05-12
7302ORIG2009-02-18