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 1 of 6 · 118 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 · 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