FDA.reportPublic FDA data

Application 017534

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003FIORINALASPIRIN; BUTALBITAL; CAFFEINETABLET;ORAL325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005FIORINALASPIRIN; BUTALBITAL; CAFFEINECAPSULE;ORAL325MG;50MG;40MGYesYes

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

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
N017534-003FIORINALASPIRIN; BUTALBITAL; CAFFEINE325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1986-04-16
N017534-005FIORINALASPIRIN; BUTALBITAL; CAFFEINE325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1986-04-16

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N017534-003FIORINAL325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1986-04-16f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N017534-005FIORINAL325MG;50MG;40MGCAPSULE / ORALRLD1986-04-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017534-003FIORINAL325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1986-04-16e64feba35796…
2022-09-29 23:25 UTC2022-09N017534-005FIORINAL325MG;50MG;40MGCAPSULE / ORALRLD1986-04-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017534-003FIORINAL325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1986-04-16cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017534-005FIORINAL325MG;50MG;40MGCAPSULE / ORALRLD1986-04-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017534-003FIORINAL325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1986-04-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017534-005FIORINAL325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD1986-04-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017534-005AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017534-005AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017534-005AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017534-005AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017534-005AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017534-005AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017534-005AA187673890dc5c…
2021-03-12 10:30 UTC2021-03N017534-005AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017534-005AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017534-005AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017534-005AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N017534-005AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017534-005AA1ea99ee380514…

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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6146FiorinalButalbital, Aspirin, and CaffeineAllergan, Inc.NDACurrent
0023-6146FiorinalButalbital, Aspirin, and CaffeineAllergan, Inc.NDACurrent
0023-6146FiorinalButalbital, Aspirin, and CaffeineAllergan, Inc.NDACurrent
0591-3219Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3219Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3219Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3219Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3219Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
33261-922Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeineAidarex Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
52544-955FiorinalButalbital, Aspirin, and CaffeineActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67230SUPPL2021-04-29
67223SUPPL2021-04-29