FDA.reportPublic FDA data

Application 022036

Type
NDA
Sponsor
CURRAX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SILENORDOXEPIN HYDROCHLORIDETABLET;ORALEQ 3MG BASEYesNo
002SILENORDOXEPIN HYDROCHLORIDETABLET;ORALEQ 6MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-4810Doxepin HydrochlorideDoxepin HydrochlorideMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-4810Doxepin HydrochlorideDoxepin HydrochlorideMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-4810Doxepin HydrochlorideDoxepin HydrochlorideMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-4811Doxepin HydrochlorideDoxepin HydrochlorideMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-4811Doxepin HydrochlorideDoxepin HydrochlorideMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-4811Doxepin HydrochlorideDoxepin HydrochlorideMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
42847-103Silenordoxepin hydrochlorideCurrax Pharmaceuticals LLCNDACurrent
42847-103Silenordoxepin hydrochlorideCurrax Pharmaceuticals LLCNDACurrent
42847-103Silenordoxepin hydrochloridePernix Therapeutics, LLCNDACurrent
42847-103Silenordoxepin hydrochlorideCurrax Pharmaceuticals LLCNDACurrent
42847-103Silenordoxepin hydrochlorideCurrax Pharmaceuticals LLCNDACurrent
42847-106Silenordoxepin hydrochlorideCurrax Pharmaceuticals LLCNDACurrent
42847-106Silenordoxepin hydrochlorideCurrax Pharmaceuticals LLCNDACurrent
42847-106Silenordoxepin hydrochlorideCurrax Pharmaceuticals LLCNDACurrent
42847-106Silenordoxepin hydrochloridePernix Therapeutics, LLCNDACurrent
42847-106Silenordoxepin hydrochlorideCurrax Pharmaceuticals LLCNDACurrent
44183-103doxepin hydrochloridedoxepin hydrochlorideCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, MacovenNDA AUTHORIZED GENERICCurrent
44183-103doxepin hydrochloridedoxepin hydrochlorideCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, MacovenNDA AUTHORIZED GENERICCurrent
44183-103doxepin hydrochloridedoxepin hydrochlorideCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, MacovenNDA AUTHORIZED GENERICCurrent
44183-106doxepin hydrochloridedoxepin hydrochlorideCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, MacovenNDA AUTHORIZED GENERICCurrent
44183-106doxepin hydrochloridedoxepin hydrochlorideCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, MacovenNDA AUTHORIZED GENERICCurrent
44183-106doxepin hydrochloridedoxepin hydrochlorideCurrax Pharmaceuticals LLC dba Cypress, Hawthorn, MacovenNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65125SUPPL2020-11-02
65086SUPPL2020-10-30
29119SUPPL2012-01-20
44670ORIG2011-02-11
21914ORIG2011-02-11
23341ORIG2010-03-31
29118ORIG2010-03-22
38116ORIG2010-03-18