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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDESPIRIT PHARMACEUTICALS LLCae0f16f6-d07a-47e1-adb8-07803c6cfb132024-12-13WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Curist Allergy ReliefFEXOFENADINE HYDROCHLORIDE 180 MGLittle Pharma, Inc.f8228938-b5e3-0fa8-e053-6294a90a1d7c2024-11-15WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Fexofenadine HClFEXOFENADINE HCLAdvanced Rx LLCc067b335-79c5-4176-a0b3-bae02a0c23f82024-09-10WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Fexofenadine HCLFEXOFENADINE HCLAkron Pharma Inc.08023b99-0634-4ac9-afd6-4f2d2e0d2c8a2024-08-20WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Allergy ReliefFEXOFENADINE HYDROCHLORIDEMagno-Humphries, Inc.1f8a2f98-7eba-48df-9589-58587d67ae0e2024-01-03WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ndc (product): 54257-170
Fexofenadine HClFEXOFENADINE HCLCamber Consumer Care1bb1bea3-b17d-4326-b037-7468add0df802023-11-06WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Allergy ReliefFEXOFENADINE HCLAllegiant Health61eebc8a-8d1e-48a2-afb1-eda9cb00ff972020-07-27WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
Fexofenadine HClFEXOFENADINE HCLProficient Rx LP3b147968-c6a8-4725-89b6-2eb443900e8f2019-11-01WarningsExact identifier
application applno (ANDA): 204507
application number: ANDA204507
ndc (product): 63187-921

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 1 of 2 · 142 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0904Indoor Outdoor Allergy ReliefFexofenadine HClWalgreensANDACurrent
0363-0904Indoor Outdoor Allergy ReliefFexofenadine HClWalgreensANDACurrent
0363-0904Indoor Outdoor Allergy ReliefFexofenadine HClWalgreensANDACurrent
0363-0904Indoor Outdoor Allergy ReliefFexofenadine HClWalgreensANDACurrent
0363-9898Fexofenadine HydrochlorideFexofenadine HydrochlorideWALGREEN CO.ANDACurrent
0363-9898Fexofenadine HydrochlorideFexofenadine HydrochlorideWALGREEN CO.ANDACurrent
0363-9898Fexofenadine HydrochlorideFexofenadine HydrochlorideWALGREEN CO.ANDACurrent
0904-7050Fexofenadine HydrochlorideFexofenadine HClMajor PharmaceuticalsANDACurrent
0904-7050Fexofenadine HydrochlorideFexofenadine HClMajor PharmaceuticalsANDACurrent
0904-7050Fexofenadine HydrochlorideFexofenadine HClMajor PharmaceuticalsANDACurrent
0904-7050Fexofenadine HydrochlorideFexofenadine HClMajor PharmaceuticalsANDACurrent
0904-7192fexofenadine hclfexofenadine hclMajor PharmaceuticalsANDACurrent
21130-405IAllergy ReliefFexofenadine HClSafeway, Inc.ANDACurrent
21130-405IAllergy ReliefFexofenadine HClSafeway, Inc.ANDACurrent
36800-652Allergy ReliefFexofenadine HydrochlorideTopCo Associates LLCANDACurrent
36800-652Allergy ReliefFexofenadine HydrochlorideTopCo Associates LLCANDACurrent
41250-506Allergy ReliefFexofenadine HClMEIJER, INC.ANDACurrent
41250-506Allergy ReliefFexofenadine HClMEIJER, INC.ANDACurrent
41250-506Allergy ReliefFexofenadine HClMEIJER, INC.ANDACurrent
41250-506Allergy ReliefFexofenadine HClMEIJER, INC.ANDACurrent
49035-764Allergy ReliefFexofenadine HClEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-764Allergy ReliefFexofenadine HClEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
50090-2457Fexofenadine HClFexofenadine HClA-S Medication SolutionsANDACurrent
50090-2457Fexofenadine HClFexofenadine HClA-S Medication SolutionsANDACurrent
50228-201fexofenadine hclfexofenadine hclScieGen Pharmaceuticals, Inc.ANDACurrent
50228-201fexofenadine hclfexofenadine hclScieGen Pharmaceuticals, Inc.ANDACurrent
50228-202fexofenadine hclfexofenadine hclScieGen Pharmaceuticals, Inc.ANDACurrent
50228-202fexofenadine hclfexofenadine hclScieGen Pharmaceuticals, Inc.ANDACurrent
50594-504Allergy ReliefFexofenadine HClBig LotsANDACurrent
50594-504Allergy ReliefFexofenadine HClBig LotsANDACurrent
50594-769Fexofenadine HydrochlorideFexofenadine HydrochlorideBig Lots Stores, Inc.ANDACurrent
50594-769Fexofenadine HydrochlorideFexofenadine HydrochlorideBig Lots Stores, Inc.ANDACurrent
50594-769Fexofenadine HydrochlorideFexofenadine HydrochlorideBig Lots Stores, Inc.ANDACurrent
50594-801Allergy ReliefFexofenadine HClBig LotsANDACurrent
50594-801Allergy ReliefFexofenadine HClBig LotsANDACurrent
50594-801Allergy ReliefFexofenadine HClBig LotsANDACurrent
50594-801Allergy ReliefFexofenadine HClBig LotsANDACurrent
51407-033fexofenadine hclfexofenadine hclGolden State Medical Supply, Inc.ANDACurrent
51407-033fexofenadine hclfexofenadine hclGolden State Medical SupplyANDACurrent
51407-034fexofenadine hclfexofenadine hclGolden State Medical Supply, Inc.ANDACurrent
51407-034fexofenadine hclfexofenadine hclGolden State Medical SupplyANDACurrent
51407-034fexofenadine hclfexofenadine hclGolden State Medical SupplyANDACurrent
53002-1409Fexofenadine HClFexofenadine HClRPK Pharmaceuticals, Inc.ANDACurrent
53002-1409Fexofenadine HClFexofenadine HClRPK Pharmaceuticals, Inc.ANDACurrent
53943-192Allergy ReliefFexofenadine HydrochlorideDISCOUNT DRUG MARTANDACurrent
53943-192ALLERGY RELIEFFexofenadine HydrochlorideDISCOUNT DRUG MARTANDACurrent
53943-192ALLERGY RELIEFFexofenadine HydrochlorideDISCOUNT DRUG MARTANDACurrent
54257-170Allergy ReliefFEXOFENADINE HYDROCHLORIDEMagno-Humphries, Inc.ANDACurrent
54257-170Allergy ReliefFEXOFENADINE HYDROCHLORIDEMagno-Humphries, Inc.ANDACurrent
54257-170Allergy ReliefFEXOFENADINE HYDROCHLORIDEMagno-Humphries, Inc.ANDACurrent
54257-702Allergy ReliefFEXOFENADINE HYDROCHLORIDEMagno-Humphries, Inc.ANDACurrent
54257-702Allergy ReliefFEXOFENADINE HYDROCHLORIDEMagno-Humphries, Inc.ANDACurrent
54257-702Allergy ReliefFEXOFENADINE HYDROCHLORIDEMagno-Humphries, Inc.ANDACurrent
54257-702Allergy ReliefFEXOFENADINE HYDROCHLORIDEMagno-Humphries, Inc.ANDACurrent
55700-500Fexofenadine HClFexofenadine HClLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-500Fexofenadine HClFexofenadine HClLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-500Fexofenadine HClFexofenadine HClLake Erie Medical DBA Quality Care Products LLCANDACurrent
57344-192Allergy ReliefFexofenadine HydrochlorideAAA Pharmaceutical, Inc.ANDACurrent
57344-192Allergy ReliefFexofenadine HydrochlorideAAA Pharmaceutical, Inc.ANDACurrent
59726-505Allergy ReliefFexofenadine HClP & L Development, LLCANDACurrent
59726-505Allergy ReliefFexofenadine HClP & L Development, LLCANDACurrent
59726-701IAllergy ReliefFexofenadine HClP & L Development, LLCANDACurrent
59726-701IAllergy ReliefFexofenadine HClP & L Development, LLCANDACurrent
59726-801Allergy ReliefFexofenadine HClP & L Development, LLCANDACurrent
59726-801Allergy ReliefFexofenadine HClP & L Development, LLCANDACurrent
59726-801Allergy ReliefFexofenadine HClP & L Development, LLCANDACurrent
59726-801Allergy ReliefFexofenadine HClP & L Development, LLCANDACurrent
59779-979Fexofenadine HClFexofenadine HClCVS PharmacyANDACurrent
63187-921Fexofenadine HClFexofenadine HClProficient Rx LPANDACurrent
63187-921Fexofenadine HClFexofenadine HClProficient Rx LPANDACurrent
63868-667Allergy ReliefFexofenadine HydrochlorideCHAIN DRUG MARKETING ASSOCIATION INC.ANDACurrent
63868-667Allergy ReliefFexofenadine HydrochlorideCHAIN DRUG MARKETING ASSOCIATION INC.ANDACurrent
63940-768Fexofenadine HydrochlorideFexofenadine HydrochlorideHARMON STORES INC.ANDACurrent
63940-768Fexofenadine HydrochlorideFexofenadine HydrochlorideHARMON STORES INC.ANDACurrent
63940-769Fexofenadine HydrochlorideFexofenadine HydrochlorideHARMON STORES INC.ANDACurrent
63940-769Fexofenadine HydrochlorideFexofenadine HydrochlorideHARMON STORES INC.ANDACurrent
68016-176Allergy ReliefFexofenadine HydrochlorideCHAIN DRUG CONSORTIUMANDACurrent
68016-176Allergy ReliefFexofenadine HydrochlorideCHAIN DRUG CONSORTIUMANDACurrent
68016-769Fexofenadine HydrochlorideFexofenadine HydrochloridePharmacy Value Alliance, LLCANDACurrent
68016-769Fexofenadine HydrochlorideFexofenadine HydrochloridePharmacy Value Alliance, LLCANDACurrent