FDA.reportPublic FDA data

Application 075588

Type
ANDA
Sponsor
CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDETABLET;ORAL200MG;30MGNoNo

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
A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEIBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08

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 UTC2026-02A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-083f01610625f2…
2019-09-15 20:21 UTC2019-09A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075588-001IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE200MG;30MGTABLET / ORAL2002-04-08cb3db0bc1861…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen and Pseudoephedrine hydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.65ec0f85-7ca3-4adc-b152-a0ae2fd0692f2025-02-27WarningsName fallback
brand name: Ibuprofen and Pseudoephedrine hydrochloride
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEThe Kroger Company2c15339d-a33b-4884-87d8-a3b50903a2c82024-12-27WarningsName fallback
brand name: Ibuprofen and Pseudoephedrine Hydrochloride
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services LLCd93ae778-e6e9-4d1d-8f46-c04d962a93932024-11-22WarningsName fallback
brand name: Ibuprofen and Pseudoephedrine Hydrochloride
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLCc01116d3-32f8-41f0-8e31-c4142265ef562024-10-24WarningsName fallback
brand name: Ibuprofen and Pseudoephedrine Hydrochloride
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN COMPANYc3b302c6-a2d2-491c-8f56-ecc25dd1f6c02022-10-07WarningsName fallback
brand name: Ibuprofen and Pseudoephedrine Hydrochloride
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDERite-Aid483c3bb7-529e-4684-80e1-6646b050988e2022-01-26WarningsName fallback
brand name: Ibuprofen and Pseudoephedrine Hydrochloride
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy627ea7db-47f1-40c2-b1ca-72dc66542e4a2021-12-21WarningsName fallback
brand name: Ibuprofen and Pseudoephedrine Hydrochloride
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.c0692a21-358d-47b9-bbff-cc8f4f3bdb562020-09-09WarningsName fallback
brand name: Ibuprofen and Pseudoephedrine Hydrochloride
Ibuprofen and Pseudoephedrine hydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.cb7fb0d3-adf6-4c14-ac61-103dc869ebf22020-09-09WarningsName fallback
brand name: Ibuprofen and Pseudoephedrine hydrochloride
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEPublix Super Markets Inc2b98a62b-bd92-4fb8-ad0f-521cb477b6122018-10-23WarningsName fallback
brand name: Ibuprofen and Pseudoephedrine Hydrochloride

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8728ORIG2004-06-07
43007ORIG2003-12-24
39490ORIG2003-12-24
30949ORIG2003-04-10