FDA.reportPublic FDA data

Application 021431

Type
NDA
Sponsor
FOREST LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAMPRALACAMPROSATE CALCIUMTABLET, DELAYED RELEASE;ORAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021431-001CAMPRALACAMPROSATE CALCIUM333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021431-001CAMPRAL333MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, DELAYED RELEASE / ORALRLD2004-07-29a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACAMPROSATE CALCIUMACAMPROSATE CALCIUMSomerset Therapeutics, LLC1cfe4675-766f-4f1a-b1a8-96bbdacfcfa52026-07-14Warnings, Adverse reactionsName fallback
generic name: ACAMPROSATE CALCIUM
acamprosate calciumACAMPROSATE CALCIUMREMEDYREPACK INC.91769a96-3182-4e38-90c3-b22c1beae3982026-05-18Warnings, Adverse reactionsName fallback
generic name: ACAMPROSATE CALCIUM
Acamprosate CalciumACAMPROSATE CALCIUMMajor Pharmaceuticalsae6e79c0-a307-4888-b647-1b7be4cb91272026-02-11Warnings, Adverse reactionsName fallback
generic name: ACAMPROSATE CALCIUM
Acamprosate CalciumACAMPROSATE CALCIUMGlenmark Pharmaceuticals Inc., USA43e9ef60-2d85-4394-906b-93042fea099a2026-01-23Warnings, Adverse reactionsName fallback
generic name: ACAMPROSATE CALCIUM
Acamprosate CalciumACAMPROSATE CALCIUMBionpharma Inc.,4473326f-79f1-61b2-e063-6294a90a17a32025-11-25Warnings, Adverse reactionsName fallback
generic name: ACAMPROSATE CALCIUM
acamprosate calciumACAMPROSATE CALCIUMZydus Pharmaceuticals (USA) Inc.9803db35-2600-4f42-80c1-43216fd1ba3d2023-11-06Warnings, Adverse reactionsName fallback
generic name: ACAMPROSATE CALCIUM
acamprosate calciumACAMPROSATE CALCIUMZydus Lifesciences Limited0c729939-d2d2-4e61-acbc-4f1646dc38c12023-11-06Warnings, Adverse reactionsName fallback
generic name: ACAMPROSATE CALCIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68151-4760Campralacamprosate calciumCarilion Materials ManagementNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
27754SUPPL2012-02-01
15448SUPPL2012-01-30
27753SUPPL2010-12-15
36903SUPPL2010-12-13
42155ORIG2004-10-18
36902ORIG2004-07-30
27752ORIG2004-07-30