FDA.reportPublic FDA data

Application 077068

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACLOFENBACLOFENTABLET;ORAL20MGNoNo
002BACLOFENBACLOFENTABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077068-001BACLOFENBACLOFEN20MGTABLET / ORALAB2005-08-30
A077068-002BACLOFENBACLOFEN10MGTABLET / ORALAB2005-08-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077068-001AB
A077068-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077068-001BACLOFEN20MGTABLET / ORALAB2005-08-30a50c72e98297…
2026-08-01 22:54:322026-06A077068-002BACLOFEN10MGTABLET / ORALAB2005-08-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077068-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077068-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENBryant Ranch Prepack7b6d33d8-58c2-448d-a8df-1de7339b15202024-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077068
application number: ANDA077068
BaclofenBACLOFENBryant Ranch Prepack4cbb2264-ef65-4906-86e5-349deeeda7a92024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077068
application number: ANDA077068
BaclofenBACLOFENBryant Ranch Prepack32525b4e-6384-49e1-a66d-abe45484ab862024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077068
application number: ANDA077068
ndc (product): 63629-2131
BaclofenBACLOFENBryant Ranch Prepacke13c0563-0f32-4199-acb0-ad2376ec951b2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077068
application number: ANDA077068
ndc (product): 63629-2130
BaclofenBACLOFENPar Health USA, LLCc17527be-661d-42f5-b6f6-56a681ba78702024-11-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077068
application number: ANDA077068
ndc (product): 0603-2407

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-2407BaclofenBaclofenPar PharmaceuticalANDACurrent
0603-2407BaclofenBaclofenPar PharmaceuticalANDACurrent
0603-2407BaclofenBaclofenPar PharmaceuticalANDACurrent
0603-2407BaclofenBaclofenPar Pharmaceutical, Inc.ANDACurrent
33261-011BaclofenBaclofenAidarex Pharmaceuticals LLCANDACurrent
50090-1801BaclofenBaclofenA-S Medication SolutionsANDACurrent
50090-1801BaclofenBaclofenA-S Medication SolutionsANDACurrent
53808-0889BaclofenBaclofenState of Florida DOH Central PharmacyANDACurrent
58517-440BaclofenBaclofenNew Horizon Rx Group, LLCANDACurrent
63629-2130BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-2130BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-2130BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-2131BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-2131BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-2131BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-3193BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-3193BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-6406BaclofenBaclofenBryant Ranch PrepackANDACurrent
63629-6406BaclofenBaclofenBryant Ranch PrepackANDACurrent
66336-486BaclofenBaclofenDispensing Solutions, Inc.ANDACurrent
68788-9735BaclofenBaclofenPreferred Pharmaceuticals, Inc.ANDACurrent
71610-391BaclofenBaclofenAphena Pharma Solutions - Tennessee, LLCANDACurrent