Application 204097

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL30MGNoNo
002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE30MGTABLET / ORAL2016-08-19
A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2016-08-19
A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2016-08-19

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204097-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2016-08-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204097-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2016-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204097-001CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY30MGTABLET / ORAL2016-08-198072bd15b7f6…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HCLFEXOFENADINE HCLWalmart Inc.353323b7-67ce-7ce6-e063-6394a90a77d42026-07-21WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
equate allergy reliefFEXOFENADINE HYDROCHLORIDEWalmart Inc.852c8ad2-fc7d-4728-b2c6-f64b960fe2ab2026-07-18WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
ndc (product): 49035-366
Goodmeds Non Drowsy Allergy ReliefFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.ae1322f5-85d6-4243-b384-2ce7f8c8d6922026-04-20WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
Fexofenadine HCLFEXOFENADINE HCLPreferred Pharmaceuticals, Inc.67679801-a8fe-4038-be71-96e1312badab2026-04-16WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
ndc (product): 68788-7449
ValuMeds Non-Drowsy Allergy Relief Fexofenadine HClFEXOFENADINE HYDROCHLORIDECabinet Health P.B.C.f9ccd673-c65f-45c6-9863-26136eb816db2026-01-06WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
Fexofenadine HCLFEXOFENADINE HCLNorthwind Health Company, LLCf7584431-11aa-8213-e053-6294a90a15852026-01-01WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
Fexofenadine HCLFEXOFENADINE HCLYYBA Corp52d50976-e63a-b3e3-e063-6294a90a6a972026-01-01WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
Fexofenadine HCLFEXOFENADINE HCLPD-Rx Pharmaceuticals, Inc.07460764-43fa-49fd-ae77-d4571cb9f9442025-10-08WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
ndc (product): 72789-196
24HR Allergy ReliefFEXOFENADINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERb72c4802-1bcb-48bc-b4b9-72167ea4643e2025-06-12WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
Fexofenadine HCLFEXOFENADINE HCLStrategic Sourcing Services722eda62-9204-400a-8db4-e4aba9cd443b2025-03-24WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
Fexofenadine HCLFEXOFENADINE HCLBryant Ranch Prepack6bc92969-0d06-4bf5-a634-80964464546c2024-08-23WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
ndc (product): 71335-1217
Allergy ReliefALLERGY RELIEFAllegiant Health89ece1b5-7604-4dce-a8a6-df5b948e3cff2024-04-17WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
Fexofenadine HCLFEXOFENADINE HCLProficient Rx LPf9a7e836-6055-484f-a197-1812204285742024-03-01WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
ndc (product): 71205-531
Fexofenadine HCLFEXOFENADINE HCLA-S Medication Solutions767b082e-915d-482f-8c6b-22b6e23bca192023-12-27WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
Fexofenadine HCLFEXOFENADINE HCLA-S Medication Solutionsb420b619-e643-43e6-9b8b-81af11fdd4ed2023-12-15WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
ndc (product): 50090-4070
Fexofenadine HCLFEXOFENADINE HCLA-S Medication Solutionsa96e6e63-3be9-4e89-ae45-b74b378997b12023-10-23WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
ndc (product): 50090-4267
Childrens Allergy ReliefFEXOFENADINE HCLPLD Acquisitions LLC DBA Avma Pharma Solutions052d6191-1d9c-45c9-8c81-d19a977eded52023-02-13WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
ndc (product): 63548-0662
Allergy ReliefFEXOFENADINE HCLPLD Acquisitions LLC DBA Avma Pharma Solutions0c83f650-f2bf-4c5b-a1e3-7c40cd9c4c6f2023-02-09WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
ndc (product): 63548-0663
Allergy ReliefFEXOFENADINE HCLPLD Acquisitions LLC DBA Avma Pharma Solutions9f1f292d-6d5f-4600-ad27-323e498ddecb2023-02-09WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
ndc (product): 63548-0664
Fexofenadine HCLFEXOFENADINE HCLNorthStar RxLLC9c308a91-640d-441b-8fb5-acb5a415405e2019-04-30WarningsExact identifier
application applno (ANDA): 204097
application number: ANDA204097
ndc (product): 16714-899

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 68 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6978Allergy ReliefFexofenadine HCLMajor PharmaceuticalsANDACurrent
0904-6978Allergy ReliefFexofenadine HCLMajor PharmaceuticalsANDACurrent
16714-899Fexofenadine HCLFexofenadine HCLNorthStar RxLLCANDACurrent
16714-899Fexofenadine HCLFexofenadine HCLNorthStar RxLLCANDACurrent
21130-064Allergy ReliefFexofenadine HClSafeway, Inc.ANDACurrent
21130-064Allergy ReliefFexofenadine HClSafeway, Inc.ANDACurrent
21130-064Allergy ReliefFexofenadine HClSafeway, Inc.ANDACurrent
41250-564Allergy ReliefFexofenadine HClMEIJER, INC.ANDACurrent
41250-564Allergy ReliefFexofenadine HClMEIJER, INC.ANDACurrent
41250-564Allergy ReliefFexofenadine HClMEIJER, INC.ANDACurrent
49035-366equate allergy relieffexofenadine hydrochlorideWalmart Inc.ANDACurrent
49035-366equate allergy relieffexofenadine hydrochlorideWalmart Inc.ANDACurrent
49035-366equate allergy relieffexofenadine hydrochlorideWalmart Inc.ANDACurrent
49035-504Allergy ReliefFexofenadine HCLEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-504Allergy ReliefFexofenadine HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
49035-504Allergy ReliefFexofenadine HCLEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
50090-4070Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4070Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4070Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4070Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4070Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4070Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4267Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
50090-4267Fexofenadine HCLFexofenadine HCLA-S Medication SolutionsANDACurrent
55700-848Fexofenadine HCLFexofenadine HCLQuality Care Products, LLCANDACurrent
55700-848Fexofenadine HCLFexofenadine HCLQuality Care Products, LLCANDACurrent
59726-564Allergy ReliefFexofenadine HCLP & L Development, LLCANDACurrent
59726-564Allergy ReliefFexofenadine HCLP & L Development, LLCANDACurrent
59726-564Allergy ReliefFexofenadine HCLP & L Development, LLCANDACurrent
59726-564Allergy ReliefFexofenadine HCLP & L Development, LLCANDACurrent
63548-0662Childrens Allergy ReliefFexofenadine HCLPLD Acquisitions LLC DBA AvANDACurrent
63548-0663Allergy ReliefFexofenadine HClPLD Acquisitions LLC DBA AvANDACurrent
63548-0664Allergy ReliefFexofenadine HClPLD Acquisitions LLC DBA AvANDACurrent
63629-7997Fexofenadine HCLFexofenadine HCLBryant Ranch PrepackANDACurrent
63941-064Allergy ReliefFexofenadine HCLBest Choice (Valu Merchandisers Company)ANDACurrent
63941-064Allergy ReliefFexofenadine HCLBest Choice (Valu Merchandisers Company)ANDACurrent
63941-064Allergy ReliefFexofenadine HCLBest Choice (Valu Merchandisers Company)ANDACurrent
68071-2682Fexofenadine HCLFexofenadine HCLNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2682Fexofenadine HCLFexofenadine HCLNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4846Fexofenadine HCLFexofenadine HCLNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4846Fexofenadine HCLFexofenadine HCLNuCare Pharmaceuticals,Inc.ANDACurrent
68554-5061Fexofenadine HydrochlorideFexofenadine HydrochlorideHetero Labs LimitedANDACurrent
68554-5062Fexofenadine HydrochlorideFexofenadine HydrochlorideHetero Labs LimitedANDACurrent
68554-5063Fexofenadine HydrochlorideFexofenadine HydrochlorideHetero Labs LimitedANDACurrent
68788-7449Fexofenadine HCLFexofenadine HCLPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7449Fexofenadine HCLFexofenadine HCLPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7449Fexofenadine HCLFexofenadine HCLPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7449Fexofenadine HCLFexofenadine HCLPreferred Pharmaceuticals, Inc.ANDACurrent
69230-300Fexofenadine HCLFexofenadine HCLCamber Consumer CareANDACurrent
69230-300Fexofenadine HCLFexofenadine HCLCamber Consumer CareANDACurrent
69230-301Fexofenadine HCLFexofenadine HCLCamber Consumer CareANDACurrent
69230-301Fexofenadine HCLFexofenadine HCLCamber Consumer CareANDACurrent
70934-601Fexofenadine HCLFexofenadine HCLDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-610Fexofenadine HCLFexofenadine HCLDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-531Fexofenadine HCLFexofenadine HCLProficient Rx LPANDACurrent
71205-531Fexofenadine HCLFexofenadine HCLProficient Rx LPANDACurrent
71335-1217Fexofenadine HCLFexofenadine HCLBryant Ranch PrepackANDACurrent
71626-502Allergy ReliefFexofenadine HCLMedstone Pharma LLCANDACurrent
71626-502Allergy ReliefFexofenadine HCLMedstone Pharma LLCANDACurrent
71626-502Allergy ReliefFexofenadine HCLMedstone Pharma LLCANDACurrent
71626-502Allergy ReliefFexofenadine HCLMedstone Pharma LLCANDACurrent
71626-502Allergy ReliefFexofenadine HCLMedstone Pharma LLCANDACurrent
71626-502Allergy ReliefFexofenadine HCLMedstone Pharma LLCANDACurrent
72090-061Fex-Allergy ReliefFexofenadine HClPioneer Life Sciences, LLCANDACurrent
72189-305FexofenadineFexofenadineDirectRxANDACurrent
72789-196Fexofenadine HCLFexofenadine HCLPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-196Fexofenadine HCLFexofenadine HCLPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-196Fexofenadine HCLFexofenadine HCLPD-Rx Pharmaceuticals, Inc.ANDACurrent