FDA.reportPublic FDA data

Application 078504

Type
ANDA
Sponsor
NORTHSTAR HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACLOFENBACLOFENTABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENNorthstar RxLLC0aac77fa-30c2-46c8-a04d-e6b8333ddd812025-11-05Warnings, Adverse reactionsExact identifier
ndc (product): 16714-071
BaclofenBACLOFENProficient Rx LPb65d3089-0412-487f-a1b4-66f0bc6f398e2022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078504
application number: ANDA078504
ndc (product): 71205-474

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-071BaclofenBaclofenNorthstar RxLLCANDACurrent
16714-071BaclofenBaclofenNorthstar RxLLCANDACurrent
16714-071BaclofenBaclofenNorthstar RxLLCANDACurrent
63739-479BaclofenBaclofenMcKesson Corporation dba SKY PackagingANDACurrent
63739-479BaclofenBaclofenMckesson Corporation DBA SKY PackaginngANDACurrent
63739-479BaclofenBaclofenMcKesson CorporationANDACurrent
63739-479BaclofenBaclofenMckesson Corporation DBA SKY PackaginngANDACurrent
71205-474BaclofenBaclofenProficient Rx LPANDACurrent
71205-474BaclofenBaclofenProficient Rx LPANDACurrent
71205-474BaclofenBaclofenProficient Rx LPANDACurrent
71205-474BaclofenBaclofenProficient Rx LPANDACurrent
71205-474BaclofenBaclofenProficient Rx LPANDACurrent
71335-0206BaclofenBaclofenBryant Ranch PrepackANDACurrent
71335-0206BaclofenBaclofenBryant Ranch PrepackANDACurrent
71335-0206BaclofenBaclofenBryant Ranch PrepackANDACurrent