Application 204507

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo
004FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDETABLET;ORAL60MGNoNo
005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDETABLET;ORAL180MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2015-09-16
A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGYFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2015-09-16
A204507-004FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE60MGTABLET / ORAL2015-09-16
A204507-005FEXOFENADINE HYDROCHLORIDE HIVESFEXOFENADINE HYDROCHLORIDE180MGTABLET / ORAL2015-09-16

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-09-14 22:38:342026-08A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-1684e616aacf4f…
2026-08-18 06:07:402026-07A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-08-18 06:07:402026-07A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204507-002FEXOFENADINE HYDROCHLORIDE ALLERGY60MGTABLET / ORAL2015-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204507-003FEXOFENADINE HYDROCHLORIDE ALLERGY180MGTABLET / ORAL2015-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204507-004FEXOFENADINE HYDROCHLORIDE HIVES60MGTABLET / ORAL2015-09-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204507-005FEXOFENADINE HYDROCHLORIDE HIVES180MGTABLET / ORAL2015-09-165bbf6a4d5a75…

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 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDENUVICARE LLCdd0da52b-fc82-4ec9-854c-0d7c52e926fb2026-08-03WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Allergy ReliefFEXOFENADINE HCLP & L Development, LLC35b807b5-2e7a-446b-b378-eb5391ddfd142026-07-22WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Curist Hives ReliefFEXOFENADINE HYDROCHLORIDE 180 MGLittle Pharma, Inc.04c75e93-b1f4-2546-e063-6394a90af0e12026-07-15WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Gencare-Allergy ReliefFEXOFENADINE HYDROCHLORIDEPioneer Life Sciences, LLCa8595b29-1ea3-44aa-b131-030f34f408fc2026-06-22WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Allergy ReliefFEXOFENADINE HCLP & L Development, LLCa976ad95-33d2-49f5-bad5-e980bf7648792026-06-08WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORP2dd5e6b0-2445-4419-b0e6-c62aadee6ea42026-03-18WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ndc (product): 73581-011
fexofenadine hclFEXOFENADINE HCLAKRON PHARMA INCfe67f0f1-c6f1-424e-8226-19176de799452026-01-19WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ndc (product): 71399-8659
Fexofenadine HydrochlorideFEXOFENADINE HCLNorthwind Health Company, LLCf2b6c157-1af1-8d43-e053-2995a90aaf1a2026-01-01WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPa1e80757-346f-4d88-8da7-55583c3a902b2025-11-26WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ndc (product): 73581-103
fexofenadine hclFEXOFENADINE HCLBryant Ranch Prepackc23ad304-a5de-454e-a135-4eb143af23812025-10-22WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ndc (product): 71335-2165
IAllergy ReliefFEXOFENADINE HCLSafeway, Inc.1f6a97e3-f84a-4c89-8e8f-6e0d111fe5002025-08-19WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
fexofenadine hclFEXOFENADINE HCLMajor Pharmaceuticals107f398c-f296-4190-8234-82556a039e652025-08-12WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Fexofenadine HydrochlorideFEXOFENADINE HCLMajor Pharmaceuticalsc34cda59-8a63-48ab-a19d-c06a1878f5da2025-07-18WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Allergy Relief non drowsyFEXOFENADINE HCLMEIJER, INC.b3395454-65db-4d8b-abce-2475b049a1142025-07-02WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
fexofenadine hclFEXOFENADINE HCLAphena Pharma Solutions - Tennessee, LLC34918a5a-c4c9-bc79-e063-6294a90acb852025-05-13WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ALLERGY RELIEFFEXOFENADINE HCLBi-Martea8d8e12-4781-4501-a887-e732295d33bf2025-04-28WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
fexofenadine hclFEXOFENADINE HCLAphena Pharma Solutions - Tennessee, LLC31e71ee7-c4b5-6c1c-e063-6294a90a15132025-04-03WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
fexofenadine hclFEXOFENADINE HCLRadha Pharmaceuticals30283df1-6394-3a91-e063-6394a90a67762025-03-10WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
fexofenadine hclFEXOFENADINE HCLScieGen Pharmaceuticals, Inc.b7e9477d-33d9-4463-b8a6-69af5f71ce352024-12-24WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDESPIRIT PHARMACEUTICALS LLC5307b7ef-0c22-4aae-a2f6-033d31032f552024-12-13WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ndc (product): 68210-4090

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 142 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-2615fexofenadine hclfexofenadine hclNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4568Fexofenadine HClFexofenadine HClNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4568Fexofenadine HClFexofenadine HClNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4568Fexofenadine HClFexofenadine HClNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4568Fexofenadine HClFexofenadine HClNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4647Fexofenadine HClFexofenadine HClNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4647Fexofenadine HClFexofenadine HClNuCare Pharmaceuticals,Inc.ANDACurrent
68210-2210Fexofenadine HydrochlorideFexofenadine HydrochlorideSPIRIT PHARMACEUTICALS LLCANDACurrent
68210-4090Fexofenadine HydrochlorideFexofenadine HydrochlorideSPIRIT PHARMACEUTICALS LLCANDACurrent
68210-4090Fexofenadine HydrochlorideFexofenadine HydrochlorideSPIRIT PHARMACEUTICALS LLCANDACurrent
68210-4090Fexofenadine HydrochlorideFexofenadine HydrochlorideSPIRIT PHARMACEUTICALS LLCANDACurrent
68210-4090Fexofenadine HydrochlorideFexofenadine HydrochlorideSPIRIT PHARMACEUTICALS LLCANDACurrent
68391-504Allergy ReliefFexofenadine HClBJWC (Berkley & Jensen / BJ's)ANDACurrent
68391-504Allergy ReliefFexofenadine HClBJWC (Berkley & Jensen / BJ's)ANDACurrent
68391-504Allergy ReliefFexofenadine HClBJWC (Berkley & Jensen / BJ's)ANDACurrent
68391-504Allergy ReliefFexofenadine HClBJWC (Berkley & Jensen / BJ's)ANDACurrent
68788-7089Fexofenadine HClFexofenadine HClPreferred PharmaceuticalsANDACurrent
68998-192Allergy ReliefFexofenadine HydrochlorideMarc Glassman, Inc.ANDACurrent
68998-192Allergy ReliefFexofenadine HydrochlorideMarc Glassman, Inc.ANDACurrent
69168-416Allergy ReliefFexofenadine HClAllegiant HealthANDACurrent
69168-416Allergy ReliefFexofenadine HClAllegiant HealthANDACurrent
69168-416Allergy ReliefFexofenadine HClAllegiant HealthANDACurrent
69168-416Allergy ReliefFexofenadine HClAllegiant HealthANDACurrent
69168-416Allergy ReliefFexofenadine HClAllegiant HealthANDACurrent
69168-416Allergy ReliefFexofenadine HClAllegiant HealthANDACurrent
69230-201Fexofenadine HClFexofenadine HClCamber Consumer CareANDACurrent
69230-202Fexofenadine HClFexofenadine HClCamber Consumer CareANDACurrent
69230-202Fexofenadine HClFexofenadine HClCamber Consumer CareANDACurrent
69848-002Fexofenadine HydrochlorideFexofenadine HydrochlorideGranules USA, IncANDACurrent
69848-002Fexofenadine HydrochlorideFexofenadine HydrochlorideGranules USA, IncANDACurrent
70518-2142Fexofenadine HClFexofenadine HClREMEDYREPACK INC.ANDACurrent
70518-2142Fexofenadine HClFexofenadine HClREMEDYREPACK INC.ANDACurrent
70518-2142Fexofenadine HClFexofenadine HClREMEDYREPACK INC.ANDACurrent
70518-3088Fexofenadine HydrochlorideFexofenadine HClREMEDYREPACK INC.ANDACurrent
71335-0506Fexofenadine HClFexofenadine HClBryant Ranch PrepackANDACurrent
71335-0506Fexofenadine HClFexofenadine HClBryant Ranch PrepackANDACurrent
71335-0506Fexofenadine HClFexofenadine HClBryant Ranch PrepackANDACurrent
71335-2165fexofenadine hclfexofenadine hclBryant Ranch PrepackANDACurrent
71399-8042Fexofenadine HCLFexofenadine HCLAkron Pharma Inc.ANDACurrent
71399-8042Fexofenadine HCLFexofenadine HCLAkron Pharma Inc.ANDACurrent
71399-8659fexofenadine hclfexofenadine hclAKRON PHARMA INCANDACurrent
71610-070fexofenadine hclfexofenadine hclAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-429Fexofenadine HydrochlorideFexofenadine HClAphena Pharma Solutions - Tennessee, LLCANDACurrent
72036-192Allergy ReliefFexofenadine HydrochlorideHarris TeeterANDACurrent
72036-192Allergy ReliefFexofenadine HydrochlorideHarris TeeterANDACurrent
72036-192Allergy ReliefFexofenadine HydrochlorideHarris TeeterANDACurrent
72036-192Allergy ReliefFexofenadine HydrochlorideHarris TeeterANDACurrent
72559-004Curist Allergy ReliefFexofenadine hydrochlorideLittle Pharma, Inc.ANDACurrent
72559-004Curist Allergy ReliefFexofenadine hydrochlorideLittle Pharma, Inc.ANDACurrent
73581-011ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPANDACurrent
73581-011ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPANDACurrent
73581-011ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPANDACurrent
73581-011ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPANDACurrent
73581-011ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPANDACurrent
73581-103ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPANDACurrent
73581-103ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPANDACurrent
73581-103ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPANDACurrent
73581-103ALLERGY RELIEFFEXOFENADINE HYDROCHLORIDEYYBA CORPANDACurrent
76519-1182FEXOFENADINE HCLFEXOFENADINE HCLH.J. Harkins Company, Inc.ANDACurrent
80539-504Allergy ReliefFexofenadine HClAllwell Health IncANDACurrent
80539-504Allergy ReliefFexofenadine HClAllwell Health IncANDACurrent
80539-504Allergy ReliefFexofenadine HClAllwell Health IncANDACurrent