FDA.reportPublic FDA data

Application 207482

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 10MG BASENoNo
002DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 25MG BASENoNo
003DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 50MG BASENoNo
004DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 75MG BASENoNo
005DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDECAPSULE;ORALEQ 100MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7052Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7052Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7052Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7052Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7052Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7053Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7053Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7053Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7053Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7054Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7054Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7054Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7055Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7055Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7055Doxepin HydrochlorideDoxepin HydrochlorideMajor PharmaceuticalsANDACurrent
61919-863DOXEPIN HCLDOXEPIN HCLDirect_RxANDACurrent
69238-1166Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1166Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1166Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1166Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1166Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1170Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1170Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1170Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1170Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1170Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1171Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1171Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1171Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1171Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1171Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1172Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1172Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1172Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1172Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1172Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1173Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1173Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1173Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
69238-1173Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
69238-1173Doxepin HydrochlorideDoxepin HydrochlorideAmneal Pharmaceuticals NY LLCANDACurrent
70518-1380Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1380Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1412Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1412Doxepin HydrochlorideDoxepin HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0072Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0072Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0072Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0780Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0780Doxepin HydrochlorideDoxepin HydrochlorideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48880ORIG2017-06-30