FDA.reportPublic FDA data

Application 009395

Type
NDA
Sponsor
GLENWOOD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003PASKALIUMPOTASSIUM AMINOSALICYLATETABLET;ORAL1GMNoNo
004PASKALIUMPOTASSIUM AMINOSALICYLATECAPSULE;ORAL500MGNoNo

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
N009395-003PASKALIUMPOTASSIUM AMINOSALICYLATE1GMTABLET / ORALApproved before 1982
N009395-004PASKALIUMPOTASSIUM AMINOSALICYLATE500MGCAPSULE / ORALApproved before 1982

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N009395-003PASKALIUM1GMTABLET / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009395-003PASKALIUM1GMTABLET / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N009395-003PASKALIUM1GMTABLET / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009395-003PASKALIUM1GMTABLET / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009395-003PASKALIUM1GMTABLET / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009395-003PASKALIUM1GMTABLET / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N009395-003PASKALIUM1GMTABLET / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N009395-003PASKALIUM1GMTABLET / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N009395-003PASKALIUM1GMTABLET / ORALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N009395-003PASKALIUM1GMTABLET / ORALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N009395-003PASKALIUM1GMTABLET / ORALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N009395-003PASKALIUM1GMTABLET / ORALApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N009395-003PASKALIUM1GMTABLET / ORALApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N009395-003PASKALIUM1GMTABLET / ORALApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N009395-003PASKALIUM1GMTABLET / ORALApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N009395-003PASKALIUM1GMTABLET / ORALApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N009395-003PASKALIUM1GMTABLET / ORALApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N009395-003PASKALIUM1GMTABLET / ORALApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N009395-003PASKALIUM1GMTABLET / ORALApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N009395-003PASKALIUM1GMTABLET / ORALApproved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N009395-004PASKALIUM500MGCAPSULE / ORALApproved before 1982782e0a99824c…