Home Applications 077081 Application 077081
Type ANDA
Sponsor MYLAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET;ORAL 180MG No No 002 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET;ORAL 30MG No No 003 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE TABLET;ORAL 60MG No No 004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE TABLET;ORAL 30MG No No 005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE TABLET;ORAL 30MG No No 006 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE TABLET;ORAL 60MG No No 007 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE TABLET;ORAL 60MG No No 008 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE TABLET;ORAL 180MG No No 009 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE TABLET;ORAL 180MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 9 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077081-001 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2007-04-16 A077081-002 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 A077081-003 FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2008-04-11 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-07-21 A077081-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2011-07-21 A077081-006 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-07-21 A077081-007 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2011-07-21 A077081-008 FEXOFENADINE HYDROCHLORIDE ALLERGY FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2011-07-21 A077081-009 FEXOFENADINE HYDROCHLORIDE HIVES FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2011-07-21
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 10 · 387 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 2026-09-14 22:38:34 2026-08 A077081-001 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2007-04-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-002 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-003 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2008-04-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-07-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077081-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-07-21 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077081-001 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL 2007-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-002 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-003 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL 2008-04-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-07-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077081-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-07-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077081-001 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2007-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-002 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-003 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2008-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-07-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077081-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-001 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2007-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-002 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-003 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2008-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-005 CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES 30MG TABLET / ORAL 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-006 FEXOFENADINE HYDROCHLORIDE ALLERGY 60MG TABLET / ORAL 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-007 FEXOFENADINE HYDROCHLORIDE HIVES 60MG TABLET / ORAL 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-008 FEXOFENADINE HYDROCHLORIDE ALLERGY 180MG TABLET / ORAL 2011-07-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077081-009 FEXOFENADINE HYDROCHLORIDE HIVES 180MG TABLET / ORAL 2011-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077081-001 FEXOFENADINE HYDROCHLORIDE 180MG TABLET / ORAL AB 2007-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077081-002 FEXOFENADINE HYDROCHLORIDE 30MG TABLET / ORAL 2008-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077081-003 FEXOFENADINE HYDROCHLORIDE 60MG TABLET / ORAL AB 2008-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077081-004 CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY 30MG TABLET / ORAL 2011-07-21 6a471c1ec25d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 81 observed states.
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 5 of 6 · 115 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join basic care allergy FEXOFENADINE HYDROCHLORIDE Amazon.com Services LLC c2f30390-3d32-4489-9df2-caf848ce040b 2024-07-17 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE CVS PHARMACY, INC 7bc13851-291a-4582-8261-13c5022fbdd1 2024-05-24 Warnings Name fallback brand name: FEXOFENADINE HYDROCHLORIDE generic name: FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE AMERISOURCE BERGEN 2a578643-adc1-44ca-83f2-9d48527bd3a4 2024-05-14 Warnings Name fallback brand name: FEXOFENADINE HYDROCHLORIDE generic name: FEXOFENADINE HYDROCHLORIDE Basic Care Allergy FEXOFENADINE HYDROCHLORIDE Amazon.com Services LLC 27202f58-a488-42cc-b63f-be892c5b4de2 2024-05-10 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE Basic Care Allergy FEXOFENADINE HYDROCHLORIDE Amazon.com Services LLC c29d281f-89dd-4c69-8572-6599400c660f 2024-04-22 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE allergy relief FEXOFENADINE HYDROCHLORIDE Walgreen Company a0738300-7262-4e43-89a6-0d0a60bd14bd 2024-02-14 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE Allergy Relief FEXOFENADINE HYDROCHLORIDE Safeway, Inc. 348b79cf-1184-46d4-a0e5-fdc24afec1a5 2024-02-09 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE Allergy Relief FEXOFENADINE HYDROCHLORIDE Magno-Humphries, Inc. 1f8a2f98-7eba-48df-9589-58587d67ae0e 2024-01-03 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE Allergy Relief FEXOFENADINE HYDROCHLORIDE AMERIFOODS TRADING COMPANY f6dc0893-b81b-4f96-e053-6294a90a856f 2023-11-02 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE Allergy Relief FEXOFENADINE HYDROCHLORIDE TOPCO ASSOCIATES LLC c4f9224c-4c3d-74bd-e053-2995a90a1452 2023-10-30 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE ORAL Aurohealth LLC e8e35d7a-a86b-4d37-979b-f454978f070b 2023-06-06 Warnings Name fallback brand name: Fexofenadine Hydrochloride Allergy Relief FEXOFENADINE HYDROCHLORIDE Chain Drug Marketing Association, Inc. fabb8c0d-b4da-ab73-e053-6394a90ab8b5 2023-05-22 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE allergy relief FEXOFENADINE HYDROCHLORIDE United Natural Foods, Inc. dba UNFI ccff9b0f-8ae5-057f-e053-2a95a90ac2b1 2023-05-17 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE kirkland signature aller fex FEXOFENADINE HYDROCHLORIDE Costco Wholesale Company 651d14d1-c5de-4cb9-9484-b05986e641ac 2023-05-02 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE Strategic Sourcing Services, LLC de438313-9790-b4ea-2d28-7a19836cf5e2 2023-04-21 Warnings Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE Crcle Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE Innovus Pharmaceuticals, Inc. f7784610-7ca5-4489-b391-f2b3f3f6549b 2023-04-08 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE Safrel Pharmaceuticals, LLC. d6120f56-ab28-2696-e053-2995a90adf47 2023-03-28 Warnings Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE Proficient Rx LP 4a9b4b7f-0441-44d3-86c7-2542ef4b119a 2022-12-01 Warnings Name fallback brand name: Fexofenadine Hydrochloride generic name: FEXOFENADINE HYDROCHLORIDE Allergy Relief FEXOFENADINE HYDROCHLORIDE HARRIS TEETER e5429440-fc89-4200-e053-2995a90afc7d 2022-11-23 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE Allergy Relief FEXOFENADINE HYDROCHLORIDE MARC GLASSMAN, INC. c4f93336-cfd8-e023-e053-2995a90a9df0 2022-10-06 Warnings Name fallback generic name: FEXOFENADINE HYDROCHLORIDE
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 · 17 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-0781 Fexofenadine Hydrochloride fexofenadine Mylan Pharmaceuticals Inc. ANDA Current 0378-0781 Fexofenadine Hydrochloride fexofenadine Mylan Pharmaceuticals Inc. ANDA Current 0378-0781 Fexofenadine Hydrochloride fexofenadine Mylan Pharmaceuticals Inc. ANDA Current 0378-0781 Fexofenadine Hydrochloride fexofenadine Mylan Pharmaceuticals Inc. ANDA Current 0378-0781 Fexofenadine Hydrochloride fexofenadine Mylan Pharmaceuticals Inc. ANDA Current 0378-0782 Fexofenadine Hydrochloride fexofenadine Mylan Pharmaceuticals Inc. ANDA Current 0378-0782 Fexofenadine Hydrochloride fexofenadine Mylan Pharmaceuticals Inc. ANDA Current 0378-0782 Fexofenadine Hydrochloride fexofenadine Mylan Pharmaceuticals Inc. ANDA Current 0378-0782 Fexofenadine Hydrochloride fexofenadine Mylan Pharmaceuticals Inc. ANDA Current 0378-0782 Fexofenadine Hydrochloride fexofenadine Mylan Pharmaceuticals Inc. ANDA Current 43353-760 Fexofenadine Hydrochloride fexofenadine Aphena Pharma Solutions - Tennessee, LLC ANDA Current 51079-547 Fexofenadine Hydrochloride fexofenadine hydrochloride Mylan Institutional Inc. ANDA Current 51079-547 Fexofenadine Hydrochloride fexofenadine hydrochloride Mylan Institutional Inc. ANDA Current 51079-548 Fexofenadine Hydrochloride fexofenadine hydrochloride Mylan Institutional Inc. ANDA Current 51079-548 Fexofenadine Hydrochloride fexofenadine hydrochloride Mylan Institutional Inc. ANDA Current 70518-0746 Fexofenadine Hydrochloride fexofenadine REMEDYREPACK INC. ANDA Current 70518-0746 Fexofenadine Hydrochloride fexofenadine REMEDYREPACK INC. ANDA Current