FDA.reportPublic FDA data

Application 018163

Type
NDA
Sponsor
SPECGX LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RESTORILTEMAZEPAMCAPSULE;ORAL15MGYesNo
002RESTORILTEMAZEPAMCAPSULE;ORAL30MGYesYes
003RESTORILTEMAZEPAMCAPSULE;ORAL7.5MGYesNo
004RESTORILTEMAZEPAMCAPSULE;ORAL22.5MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-9914RESTORILtemazepamSpecGx LLCNDACurrent
0406-9914RESTORILtemazepamSpecGx LLCNDACurrent
0406-9914RESTORILtemazepamSpecGx LLCNDACurrent
0406-9915RESTORILtemazepamSpecGx LLCNDACurrent
0406-9915RESTORILtemazepamSpecGx LLCNDACurrent
0406-9915RESTORILtemazepamSpecGx LLCNDACurrent
0406-9916RESTORILtemazepamSpecGx LLCNDACurrent
0406-9916RESTORILtemazepamSpecGx LLCNDACurrent
0406-9916RESTORILtemazepamSpecGx LLCNDACurrent
0406-9917RESTORILtemazepamSpecGx LLCNDACurrent
0406-9917RESTORILtemazepamSpecGx LLCNDACurrent
0406-9917RESTORILtemazepamSpecGx LLCNDACurrent
0406-9959TEMAZEPAMtemazepamSpecGx LLCNDACurrent
0406-9959TEMAZEPAMtemazepamSpecGx LLCNDACurrent
0406-9959TEMAZEPAMtemazepamSpecGx LLCNDACurrent
0406-9960TEMAZEPAMtemazepamSpecGx LLCNDACurrent
0406-9960TEMAZEPAMtemazepamSpecGx LLCNDACurrent
0406-9960TEMAZEPAMtemazepamSpecGx LLCNDACurrent
0406-9961TEMAZEPAMtemazepamSpecGx LLCNDACurrent
0406-9961TEMAZEPAMtemazepamSpecGx LLCNDACurrent
0406-9962TEMAZEPAMtemazepamSpecGx LLCNDACurrent
0406-9962TEMAZEPAMtemazepamSpecGx LLCNDACurrent
50090-3563TEMAZEPAMtemazepamA-S Medication SolutionsNDACurrent
50090-3563TEMAZEPAMtemazepamA-S Medication SolutionsNDACurrent
60760-959TEMAZEPAMtemazepamSt. Mary's Medical Park PharmacyNDACurrent
68084-549TEMAZEPAMtemazepamAmerican Health PackagingNDACurrent
68084-549TemazepamTemazepamAmerican Health PackagingNDACurrent
68084-549TEMAZEPAMtemazepamAmerican Health PackagingNDACurrent
68084-549TEMAZEPAMtemazepamAmerican Health PackagingNDACurrent
70518-3057TEMAZEPAMtemazepamREMEDYREPACK INC.NDACurrent
71610-004TEMAZEPAMtemazepamAphena Pharma Solutions -NDACurrent
71610-004TEMAZEPAMtemazepamAphena Pharma Solutions - Tennessee, LLCNDACurrent
71610-625TEMAZEPAMtemazepamAphena Pharma Solutions - Tennessee, LLCNDACurrent
71610-626TEMAZEPAMtemazepamAphena Pharma Solutions - Tennessee, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73231SUPPL2023-01-17
73230SUPPL2023-01-17
73171SUPPL2023-01-17
66180SUPPL2021-02-10
66179SUPPL2021-02-10
66130SUPPL2021-02-09
57596SUPPL2019-02-14
57477SUPPL2019-02-07
57476SUPPL2019-02-07
46631SUPPL2016-12-30
46464SUPPL2016-12-22
46313SUPPL2016-12-20
14935SUPPL2010-11-12
11174SUPPL2010-11-12
14937SUPPL2008-02-27
863SUPPL2008-02-27
33449SUPPL2008-02-26
11175SUPPL2008-02-26
44020ORIG2007-03-16
14936SUPPL2004-11-08
862SUPPL2002-06-03