FDA.reportPublic FDA data

Application 077088

Type
ANDA
Sponsor
OXFORD 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
A077088-001BACLOFENBACLOFEN20MGTABLET / ORALAB2007-10-31
A077088-002BACLOFENBACLOFEN10MGTABLET / ORALAB2007-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077088-001AB
A077088-002AB

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 22:54:322026-06A077088-001BACLOFEN20MGTABLET / ORALAB2007-10-31a50c72e98297…
2026-08-01 22:54:322026-06A077088-002BACLOFEN10MGTABLET / ORALAB2007-10-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077088-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077088-002AB1a50c72e98297…

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 9 · 170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BaclofenBACLOFENCardinal Health 107, LLC3c87e116-871d-46b8-897b-fc27a17b988d2026-07-24Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN
BaclofenBACLOFENPreferred Pharmaceuticals Inc.3047613d-006b-4011-b5fe-098588f474aa2026-07-22Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN
BaclofenBACLOFENREMEDYREPACK INC.6274e70a-fb57-461b-b1bc-39d4ff916b2a2026-07-14Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN
BaclofenBACLOFENAtlantic Biologicals Corp.50b3e7be-832b-313d-e063-6394a90a5ab42026-07-14Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN
BaclofenBACLOFENREMEDYREPACK INC.ebbfec9e-621c-4d04-8a1c-81d2eb9e9c742026-06-30Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN
BaclofenBACLOFENAvPAKc21095a9-17b1-555a-e053-2a95a90a51fd2026-06-29Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN
BACLOFENBACLOFENNuCare Pharmaceuticals, Inc.2517f71f-f452-1f56-e063-6394a90a6ef12026-06-25Warnings, Adverse reactionsName fallback
brand name: BACLOFEN
generic name: BACLOFEN
BACLOFENBACLOFENRedpharm Drug53df4b4b-842e-9e3a-e063-6394a90a8a3d2026-06-10Warnings, Adverse reactionsName fallback
brand name: BACLOFEN
generic name: BACLOFEN
BaclofenBACLOFENREMEDYREPACK INC.d689d32c-12a7-4ae4-afc3-8a353be671482026-06-01Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN
BaclofenBACLOFENEywa Pharma Inc7ec59f6b-7c4f-432d-ba27-442861806b6c2026-05-16Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN
BACLOFENBACLOFENREMEDYREPACK INC.e017a001-8cb1-4dd8-960e-c6d74005f57f2026-05-12Warnings, Adverse reactionsName fallback
brand name: BACLOFEN
generic name: BACLOFEN
BaclofenBACLOFENAvPAKbc9040d9-1c54-9d62-e053-2a95a90a6ae32026-05-06Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN
BaclofenBACLOFENCoupler LLC5023c690-fd86-bb7d-e063-6394a90af6cd2026-04-23Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN
BaclofenBACLOFENCardinal Health 107, LLC2278954a-7605-426a-ae85-1bf0a31174202026-04-22Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN
BaclofenBACLOFENGolden State Medical Supply, Inc.32336e92-89a4-7d7f-e063-6394a90ae9242026-04-21Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN
BACLOFENBACLOFENREMEDYREPACK INC.ac9b720f-b755-49f1-9850-efb26feadaeb2026-04-14Warnings, Adverse reactionsName fallback
brand name: BACLOFEN
generic name: BACLOFEN
BACLOFENBACLOFENCardinal Health 107, LLCa0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c2026-04-13Warnings, Adverse reactionsName fallback
brand name: BACLOFEN
generic name: BACLOFEN
BACLOFENBACLOFENREMEDYREPACK INC.355266e4-68f7-47d7-9f4e-1a0fc912786d2026-04-10Warnings, Adverse reactionsName fallback
brand name: BACLOFEN
generic name: BACLOFEN
BACLOFENBACLOFENMedcore LLC13eca70c-3cc8-4317-83cf-ade3327e48c02026-04-01Warnings, Adverse reactionsName fallback
brand name: BACLOFEN
generic name: BACLOFEN
BaclofenBACLOFENRosemont Pharmaceuticals LLC81a539b3-e547-4a62-ad1b-2eedb30be9272026-03-30Warnings, Adverse reactionsName fallback
brand name: Baclofen
generic name: BACLOFEN