FDA.reportPublic FDA data

Application 076208

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATETABLET, EXTENDED RELEASE;ORAL5MG;120MGNoNo

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
A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATELORATADINE; PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28c2088c7a36db…
2026-09-14 22:38:342026-08A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-2884e616aacf4f…
2026-08-18 06:07:402026-07A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-283f01610625f2…
2019-09-15 20:21 UTC2019-09A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076208-001LORATADINE AND PSEUDOEPHEDRINE SULFATE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2004-01-283a93d1ddd44b…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEMajor Pharmaceuticals2620a150-4a2c-4fa2-a0e4-6aafe9e496c32025-09-08WarningsName fallback
brand name: Loratadine and Pseudoephedrine Sulfate
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEThe Kroger Company43e53450-9630-4161-8008-22267a7853432025-04-24WarningsName fallback
brand name: Loratadine and Pseudoephedrine Sulfate
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEWAL-MART STORES, INC59453133-20bf-4f13-855a-b47b22302d8b2025-04-14WarningsName fallback
brand name: Loratadine and Pseudoephedrine Sulfate
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEStrategic Sourcing Services LLCcdecad62-bf1e-43fb-b4be-8fc54b63e4ae2024-11-22WarningsName fallback
brand name: Loratadine and Pseudoephedrine Sulfate
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEStrategic Sourcing Services LLC48bfc938-d97d-4b49-8637-3b00ac8709022024-11-21WarningsName fallback
brand name: Loratadine and Pseudoephedrine Sulfate
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEMeijer Distribution, Inc.eb6e2196-2f4f-4fe9-9c80-b4ce89da8db42023-08-23WarningsName fallback
brand name: Loratadine and Pseudoephedrine Sulfate
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATESafeway Inc.c1e1e0ca-30df-4ace-a7b6-c66a3c5ab6762021-12-21WarningsName fallback
brand name: Loratadine and Pseudoephedrine Sulfate
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEAmerisource Bergen3013f7b8-d87c-41ab-ba6f-c4d1b39cb1c12021-06-03WarningsName fallback
brand name: Loratadine and Pseudoephedrine Sulfate
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATESTRATEGIC SOURCING SERVICES114b5e7c-973a-4a34-8538-a214de090b392020-07-30WarningsName fallback
brand name: Loratadine and Pseudoephedrine Sulfate
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEPublix Super Markets Inc63b73a3e-4f3a-40f1-98c0-13a2bca4f4e02018-10-22WarningsName fallback
brand name: Loratadine and Pseudoephedrine Sulfate
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEHEB0504f63e-e89c-49ad-9094-65fac328482e2018-05-24WarningsName fallback
brand name: Loratadine and Pseudoephedrine Sulfate
Loratadine and Pseudoephedrine SulfateLORATADINE AND PSEUDOEPHEDRINE SULFATEHEB74e7670a-5eca-4556-a860-0d36e85615182018-04-12WarningsName fallback
brand name: Loratadine and Pseudoephedrine Sulfate

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31098ORIG2004-01-29