FDA.reportPublic FDA data

Application 215434

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL60MG;120MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-315c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-313f0d92c62455…
2023-05-13 08:27 UTC2023-05A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31053a50430f4f…
2023-01-26 05:58 UTC2023-01A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215434-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2022-05-31a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEKroger Companyac67476a-2888-53c4-0a10-7f73ac2580c52025-12-10WarningsExact identifier
application applno (ANDA): 215434
application number: ANDA215434
ndc (product): 30142-097
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDERite Aid Corporation0834bda9-e793-ad67-7f71-d2ffce47e5fc2025-12-10WarningsExact identifier
application applno (ANDA): 215434
application number: ANDA215434
ndc (product): 11822-0021
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWalgreens Companydb671b6e-7233-8872-0227-6da62d6b65072025-12-10WarningsExact identifier
application applno (ANDA): 215434
application number: ANDA215434
ndc (product): 0363-0044
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWal-mart Stores, Inc.a0ce5002-08e3-c21f-9b88-f3dd27dc9dda2025-12-10WarningsExact identifier
application applno (ANDA): 215434
application number: ANDA215434
ndc (product): 79903-108
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEStrategic Sourcing Services, LLC23fdb518-8dcc-3671-f116-ea8c7b0a6e082025-12-10WarningsExact identifier
application applno (ANDA): 215434
application number: ANDA215434
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Health Corpb009e6b1-57da-a002-1a9e-38a96cc041f12025-12-10WarningsExact identifier
application applno (ANDA): 215434
application number: ANDA215434
ndc (product): 51316-015

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0044Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideWalgreens CompanyANDACurrent
11822-0021Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideRite Aid CorporationANDACurrent
11822-0021Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideRite Aid CorporationANDACurrent
30142-097Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideKroger CompanyANDACurrent
51316-015Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideCVS Health CorpANDACurrent
51316-015Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideCVS Health CorpANDACurrent
79903-108Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideWal-mart Stores, Inc.ANDACurrent
79903-108Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideWal-mart Stores, Inc.ANDACurrent