FDA.reportPublic FDA data

Application 070791

Type
ANDA
Sponsor
MYLAN PHARMS INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1049Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1049Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1049Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3125Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3125Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-3125Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4250Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4250Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-4250Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5375Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5375Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-5375Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6410Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6410Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-6410Doxepin Hydrochloridedoxepin hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
21695-943Doxepin HydrochlorideDoxepin HydrochlorideRebel Distributors CorpANDACurrent
35356-424Doxepin Hydrochloridedoxepin hydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-650Doxepin Hydrochloridedoxepin hydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
35356-650Doxepin Hydrochloridedoxepin hydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
43353-329Doxepin Hydrochloridedoxepin hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-331Doxepin Hydrochloridedoxepin hydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent
45865-775Doxepin Hydrochloridedoxepin hydrochlorideMedsource PharmaceuticalsANDACurrent
45865-775Doxepin Hydrochloridedoxepin hydrochlorideMedsource PharmaceuticalsANDACurrent
45865-849Doxepin Hydrochloridedoxepin hydrochlorideMedsource PharmaceuticalsANDACurrent
49999-190Doxepin Hydrochloridedoxepin hydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLCANDACurrent
50090-0278Doxepin Hydrochloridedoxepin hydrochlorideA-S Medication SolutionsANDACurrent
50090-0278Doxepin Hydrochloridedoxepin hydrochlorideA-S Medication SolutionsANDACurrent
51079-436Doxepin Hydrochloridedoxepin hydrochlorideMylan Institutional Inc.ANDACurrent
51079-436Doxepin Hydrochloridedoxepin hydrochlorideMylan Institutional Inc.ANDACurrent
51079-437Doxepin Hydrochloridedoxepin hydrochlorideMylan Institutional Inc.ANDACurrent
51079-437Doxepin Hydrochloridedoxepin hydrochlorideMylan Institutional Inc.ANDACurrent
51079-438Doxepin Hydrochloridedoxepin hydrochlorideMylan Institutional Inc.ANDACurrent
51079-438Doxepin Hydrochloridedoxepin hydrochlorideMylan Institutional Inc.ANDACurrent
51079-651Doxepin Hydrochloridedoxepin hydrochlorideMylan Institutional Inc.ANDACurrent
51079-651Doxepin Hydrochloridedoxepin hydrochlorideMylan Institutional Inc.ANDACurrent
52959-662Doxepin Hydrochloridedoxepin hydrochlorideH.J. Harkins Company, Inc.ANDACurrent
53217-070Doxepin Hydrochloridedoxepin hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
55289-018Doxepin Hydrochloridedoxepin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-258Doxepin Hydrochloridedoxepin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-370Doxepin Hydrochloridedoxepin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-370Doxepin Hydrochloridedoxepin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-370Doxepin Hydrochloridedoxepin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-370Doxepin Hydrochloridedoxepin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-370Doxepin Hydrochloridedoxepin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-370Doxepin Hydrochloridedoxepin hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
60429-966Doxepin Hydrochloridedoxepin hydrochlorideGSMS, IncorporatedANDACurrent
60429-966Doxepin Hydrochloridedoxepin hydrochlorideGSMS, IncorporatedANDACurrent
60429-966Doxepin Hydrochloridedoxepin hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-967Doxepin Hydrochloridedoxepin hydrochlorideGSMS, IncorporatedANDACurrent
60429-967Doxepin Hydrochloridedoxepin hydrochlorideGSMS, IncorporatedANDACurrent
60429-967Doxepin Hydrochloridedoxepin hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-968Doxepin Hydrochloridedoxepin hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-968Doxepin Hydrochloridedoxepin hydrochlorideGSMS, IncorporatedANDACurrent
60429-968Doxepin Hydrochloridedoxepin hydrochlorideGSMS, IncorporatedANDACurrent
60429-969Doxepin Hydrochloridedoxepin hydrochlorideGSMS, IncorporatedANDACurrent
60429-969Doxepin Hydrochloridedoxepin hydrochlorideGSMS, IncorporatedANDACurrent
60429-969Doxepin Hydrochloridedoxepin hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
60429-970Doxepin Hydrochloridedoxepin hydrochlorideGSMS, IncorporatedANDACurrent
60429-970Doxepin Hydrochloridedoxepin hydrochlorideGSMS, IncorporatedANDACurrent
60429-970Doxepin Hydrochloridedoxepin hydrochlorideGolden State Medical Supply, Inc.ANDACurrent
61919-081doxepin hydrochloridedoxepin hydrochlorideDIRECT RXANDACurrent
61919-567DOXEPIN HYDROCHLORIDEDOXEPIN HYDROCHLORIDEDIRECT RXANDACurrent
63629-3221Doxepin Hydrochloridedoxepin hydrochlorideBryant Ranch PrepackANDACurrent
63629-3221Doxepin Hydrochloridedoxepin hydrochlorideBryant Ranch PrepackANDACurrent
63629-5033Doxepin Hydrochloridedoxepin hydrochlorideBryant Ranch PrepackANDACurrent
63629-5033Doxepin Hydrochloridedoxepin hydrochlorideBryant Ranch PrepackANDACurrent
63629-5033Doxepin Hydrochloridedoxepin hydrochlorideBryant Ranch PrepackANDACurrent
64725-5375Doxepin Hydrochloridedoxepin hydrochlorideTYA PharmaceuticalsANDACurrent
67046-131Doxepin HydrochlorideDoxepin HydrochlorideContract Pharmacy Services-PAANDACurrent
67046-132Doxepin HydrochlorideDoxepin HydrochlorideContract Pharmacy Services-PAANDACurrent
67046-133Doxepin HydrochlorideDoxepin HydrochlorideContract Pharmacy Services-PAANDACurrent
68071-2314Doxepin Hydrochloridedoxepin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2314Doxepin Hydrochloridedoxepin hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-1488Doxepin Hydrochloridedoxepin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1488Doxepin Hydrochloridedoxepin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1525Doxepin Hydrochloridedoxepin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1532Doxepin Hydrochloridedoxepin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1532Doxepin Hydrochloridedoxepin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1555Doxepin Hydrochloridedoxepin hydrochlorideREMEDYREPACK INC.ANDACurrent
70518-1555Doxepin Hydrochloridedoxepin hydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18341SUPPL2014-09-05