FDA.reportPublic FDA data

Application 209102

Type
ANDA
Sponsor
RUBICON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACLOFENBACLOFENTABLET;ORAL5MGNoNo
002BACLOFENBACLOFENTABLET;ORAL10MGNoNo
003BACLOFENBACLOFENTABLET;ORAL20MGNoNo
004BACLOFENBACLOFENTABLET;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
17856-0319BACLOFENBACLOFENATLANTIC BIOLOGICALS CORP.ANDACurrent
52817-319BACLOFENBACLOFENTruPharma LLCANDACurrent
52817-319BACLOFENBACLOFENTruPharma LLCANDACurrent
52817-319BACLOFENbaclofenTruPharma LLCANDACurrent
52817-320BACLOFENBACLOFENTruPharma LLCANDACurrent
52817-320BACLOFENBACLOFENTruPharma LLCANDACurrent
52817-320BACLOFENbaclofenTruPharma LLCANDACurrent
52817-321BACLOFENBACLOFENTruPharma LLCANDACurrent
52817-321BACLOFENBACLOFENTruPharma LLCANDACurrent
52817-321BACLOFENbaclofenTruPharma LLCANDACurrent
70518-3614BACLOFENBACLOFENREMEDYREPACK INC.ANDACurrent
70934-918BACLOFENBACLOFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-918BACLOFENBACLOFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-918BACLOFENBACLOFENDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0949BACLOFENBACLOFENBryant Ranch PrepackANDACurrent
71335-0949BACLOFENbaclofenBryant Ranch PrepackANDACurrent
71335-0949BACLOFENBACLOFENBryant Ranch PrepackANDACurrent
72888-009BACLOFENBACLOFENAdvagen Pharma LimitedANDACurrent
72888-009BACLOFENBACLOFENAdvagen Pharma LimitedANDACurrent
72888-009BACLOFENBACLOFENAdvagen Pharma LimitedANDACurrent
72888-009BACLOFENBACLOFENAdvagen Pharma LimitedANDACurrent
72888-010BACLOFENBACLOFENAdvagen Pharma LimitedANDACurrent
72888-010BACLOFENBACLOFENAdvagen Pharma LimitedANDACurrent
72888-010BACLOFENBACLOFENAdvagen Pharma LimitedANDACurrent
72888-010BACLOFENBACLOFENAdvagen Pharma LimitedANDACurrent
72888-011BACLOFENBACLOFENAdvagen Pharma LimitedANDACurrent
72888-011BACLOFENBACLOFENAdvagen Pharma LimitedANDACurrent
72888-011BACLOFENBACLOFENAdvagen Pharma LimitedANDACurrent
72888-011BACLOFENBACLOFENAdvagen Pharma LimitedANDACurrent
80425-0157BaclofenBaclofen 20mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0157BaclofenBaclofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0157BaclofenBaclofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0157BaclofenBaclofenAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50740ORIG2017-12-18