FDA.reportPublic FDA data

Application 022368

Type
NDA
Sponsor
PHARMAXIS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARIDOL KITMANNITOLPOWDER;INHALATIONN/A,5MG,10MG,20MG,40MGYesYes
002ARIDOLMANNITOLPOWDER; INHALATION10MGYesNo
003ARIDOLMANNITOLPOWDER; INHALATION20MGYesNo
004ARIDOLMANNITOLPOWDER; INHALATION40MGYesNo

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

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
N022368-001ARIDOL KITMANNITOLN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-0587673890dc5c…
2021-03-12 10:30 UTC2021-03N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-053f01610625f2…
2019-09-15 20:21 UTC2019-09N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05b00525d2431f…
2019-07-19 19:46 UTC2019-07N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-053f0d92c62455…
2023-05-13 08:27 UTC2023-05N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05053a50430f4f…
2023-01-26 05:58 UTC2023-01N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022368-001ARIDOL KITN/A,5MG,10MG,20MG,40MGPOWDER / INHALATIONRLD, RS2010-10-05cb3db0bc1861…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aridol Bronchial Challenge Test KitMANNITOLMethapharm, Inc.5387a4fb-b894-4cba-88a3-a947217d34da2026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022368
application number: NDA022368
ndc (product): 67850-552

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67850-552Aridol Bronchial Challenge Test KitmannitolMethapharm, Inc.NDACurrent
67850-552Aridol Bronchial Challenge Test KitmannitolMethapharm, Inc.NDACurrent
67850-552Aridol Bronchial Challenge Test KitmannitolMethapharm, Inc.NDACurrent
67850-552Aridol Bronchial Challenge Test KitmannitolMethapharm, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68392SUPPL2021-08-17
68373SUPPL2021-08-16
44743ORIG2011-05-19
22005ORIG2011-05-19
38628ORIG2010-10-13
7298ORIG2010-10-12
53331ORIG1900-01-01
53330ORIG1900-01-01
53329ORIG1900-01-01