Home Applications 022071 Application 022071
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LAMISIL TERBINAFINE HYDROCHLORIDE GRANULE;ORAL EQ 125MG BASE/PACKET Yes No 002 LAMISIL TERBINAFINE HYDROCHLORIDE GRANULE;ORAL EQ 187.5MG BASE/PACKET Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022071-001 LAMISIL TERBINAFINE HYDROCHLORIDE EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 N022071-002 LAMISIL TERBINAFINE HYDROCHLORIDE EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28
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 3 · 86 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 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022071-001 LAMISIL EQ 125MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022071-002 LAMISIL EQ 187.5MG BASE/PACKET GRANULE / ORAL RLD 2007-09-28 74a2ff9319b5…
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 4 of 4 · 61 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.