Home Applications 204097 Application 204097
Type ANDA
Sponsor HETERO LABS LTD V Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE TABLET;ORAL 30MG No No 002 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE TABLET;ORAL 60MG No No 003 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE TABLET;ORAL 180MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2016-08-19 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2016-08-19 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2016-08-19
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 4 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 e64feba35796…2022-09-29 23:25 UTC 2022-09 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 e64feba35796…2022-09-29 23:25 UTC 2022-09 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204097-001 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2016-08-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204097-002 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2016-08-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204097-003 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2016-08-19 a50c72e98297…
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 · 20 matching rows.
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 1 · 68 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0904-6978 Allergy Relief Fexofenadine HCL Major Pharmaceuticals ANDA Current 0904-6978 Allergy Relief Fexofenadine HCL Major Pharmaceuticals ANDA Current 16714-899 Fexofenadine HCL Fexofenadine HCL NorthStar RxLLC ANDA Current 16714-899 Fexofenadine HCL Fexofenadine HCL NorthStar RxLLC ANDA Current 21130-064 Allergy Relief Fexofenadine HCl Safeway, Inc. ANDA Current 21130-064 Allergy Relief Fexofenadine HCl Safeway, Inc. ANDA Current 21130-064 Allergy Relief Fexofenadine HCl Safeway, Inc. ANDA Current 41250-564 Allergy Relief Fexofenadine HCl MEIJER, INC. ANDA Current 41250-564 Allergy Relief Fexofenadine HCl MEIJER, INC. ANDA Current 41250-564 Allergy Relief Fexofenadine HCl MEIJER, INC. ANDA Current 49035-366 equate allergy relief fexofenadine hydrochloride Walmart Inc. ANDA Current 49035-366 equate allergy relief fexofenadine hydrochloride Walmart Inc. ANDA Current 49035-366 equate allergy relief fexofenadine hydrochloride Walmart Inc. ANDA Current 49035-504 Allergy Relief Fexofenadine HCL EQUATE (Wal-Mart Stores, Inc.) ANDA Current 49035-504 Allergy Relief Fexofenadine HCL EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) ANDA Current 49035-504 Allergy Relief Fexofenadine HCL EQUATE (Wal-Mart Stores, Inc.) ANDA Current 50090-4070 Fexofenadine HCL Fexofenadine HCL A-S Medication Solutions ANDA Current 50090-4070 Fexofenadine HCL Fexofenadine HCL A-S Medication Solutions ANDA Current 50090-4070 Fexofenadine HCL Fexofenadine HCL A-S Medication Solutions ANDA Current 50090-4070 Fexofenadine HCL Fexofenadine HCL A-S Medication Solutions ANDA Current 50090-4070 Fexofenadine HCL Fexofenadine HCL A-S Medication Solutions ANDA Current 50090-4070 Fexofenadine HCL Fexofenadine HCL A-S Medication Solutions ANDA Current 50090-4267 Fexofenadine HCL Fexofenadine HCL A-S Medication Solutions ANDA Current 50090-4267 Fexofenadine HCL Fexofenadine HCL A-S Medication Solutions ANDA Current 55700-848 Fexofenadine HCL Fexofenadine HCL Quality Care Products, LLC ANDA Current 55700-848 Fexofenadine HCL Fexofenadine HCL Quality Care Products, LLC ANDA Current 59726-564 Allergy Relief Fexofenadine HCL P & L Development, LLC ANDA Current 59726-564 Allergy Relief Fexofenadine HCL P & L Development, LLC ANDA Current 59726-564 Allergy Relief Fexofenadine HCL P & L Development, LLC ANDA Current 59726-564 Allergy Relief Fexofenadine HCL P & L Development, LLC ANDA Current 63548-0662 Childrens Allergy Relief Fexofenadine HCL PLD Acquisitions LLC DBA Av ANDA Current 63548-0663 Allergy Relief Fexofenadine HCl PLD Acquisitions LLC DBA Av ANDA Current 63548-0664 Allergy Relief Fexofenadine HCl PLD Acquisitions LLC DBA Av ANDA Current 63629-7997 Fexofenadine HCL Fexofenadine HCL Bryant Ranch Prepack ANDA Current 63941-064 Allergy Relief Fexofenadine HCL Best Choice (Valu Merchandisers Company) ANDA Current 63941-064 Allergy Relief Fexofenadine HCL Best Choice (Valu Merchandisers Company) ANDA Current 63941-064 Allergy Relief Fexofenadine HCL Best Choice (Valu Merchandisers Company) ANDA Current 68071-2682 Fexofenadine HCL Fexofenadine HCL NuCare Pharmaceuticals,Inc. ANDA Current 68071-2682 Fexofenadine HCL Fexofenadine HCL NuCare Pharmaceuticals,Inc. ANDA Current 68071-4846 Fexofenadine HCL Fexofenadine HCL NuCare Pharmaceuticals,Inc. ANDA Current 68071-4846 Fexofenadine HCL Fexofenadine HCL NuCare Pharmaceuticals,Inc. ANDA Current 68554-5061 Fexofenadine Hydrochloride Fexofenadine Hydrochloride Hetero Labs Limited ANDA Current 68554-5062 Fexofenadine Hydrochloride Fexofenadine Hydrochloride Hetero Labs Limited ANDA Current 68554-5063 Fexofenadine Hydrochloride Fexofenadine Hydrochloride Hetero Labs Limited ANDA Current 68788-7449 Fexofenadine HCL Fexofenadine HCL Preferred Pharmaceuticals, Inc. ANDA Current 68788-7449 Fexofenadine HCL Fexofenadine HCL Preferred Pharmaceuticals, Inc. ANDA Current 68788-7449 Fexofenadine HCL Fexofenadine HCL Preferred Pharmaceuticals, Inc. ANDA Current 68788-7449 Fexofenadine HCL Fexofenadine HCL Preferred Pharmaceuticals, Inc. ANDA Current 69230-300 Fexofenadine HCL Fexofenadine HCL Camber Consumer Care ANDA Current 69230-300 Fexofenadine HCL Fexofenadine HCL Camber Consumer Care ANDA Current 69230-301 Fexofenadine HCL Fexofenadine HCL Camber Consumer Care ANDA Current 69230-301 Fexofenadine HCL Fexofenadine HCL Camber Consumer Care ANDA Current 70934-601 Fexofenadine HCL Fexofenadine HCL Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 70934-610 Fexofenadine HCL Fexofenadine HCL Denton Pharma, Inc. dba Northwind Pharmaceuticals ANDA Current 71205-531 Fexofenadine HCL Fexofenadine HCL Proficient Rx LP ANDA Current 71205-531 Fexofenadine HCL Fexofenadine HCL Proficient Rx LP ANDA Current 71335-1217 Fexofenadine HCL Fexofenadine HCL Bryant Ranch Prepack ANDA Current 71626-502 Allergy Relief Fexofenadine HCL Medstone Pharma LLC ANDA Current 71626-502 Allergy Relief Fexofenadine HCL Medstone Pharma LLC ANDA Current 71626-502 Allergy Relief Fexofenadine HCL Medstone Pharma LLC ANDA Current 71626-502 Allergy Relief Fexofenadine HCL Medstone Pharma LLC ANDA Current 71626-502 Allergy Relief Fexofenadine HCL Medstone Pharma LLC ANDA Current 71626-502 Allergy Relief Fexofenadine HCL Medstone Pharma LLC ANDA Current 72090-061 Fex-Allergy Relief Fexofenadine HCl Pioneer Life Sciences, LLC ANDA Current 72189-305 Fexofenadine Fexofenadine DirectRx ANDA Current 72789-196 Fexofenadine HCL Fexofenadine HCL PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-196 Fexofenadine HCL Fexofenadine HCL PD-Rx Pharmaceuticals, Inc. ANDA Current 72789-196 Fexofenadine HCL Fexofenadine HCL PD-Rx Pharmaceuticals, Inc. ANDA Current