Home Applications 022545 Application 022545
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TEKAMLO ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE TABLET;ORAL EQ 150MG BASE;EQ 5MG BASE No No 002 TEKAMLO ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE TABLET;ORAL EQ 150MG BASE;EQ 10MG BASE No No 003 TEKAMLO ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE TABLET;ORAL EQ 300MG BASE;EQ 5MG BASE No No 004 TEKAMLO ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE TABLET;ORAL EQ 300MG BASE;EQ 10MG BASE No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022545-001 TEKAMLO ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE EQ 150MG BASE;EQ 5MG BASE TABLET / ORAL 2010-08-26 N022545-002 TEKAMLO ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE EQ 150MG BASE;EQ 10MG BASE TABLET / ORAL 2010-08-26 N022545-003 TEKAMLO ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE EQ 300MG BASE;EQ 5MG BASE TABLET / ORAL 2010-08-26 N022545-004 TEKAMLO ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE EQ 300MG BASE;EQ 10MG BASE TABLET / ORAL 2010-08-26
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022545-001 8613949 2029-12-21 Drug product N022545-002 8613949 2029-12-21 Drug product N022545-003 8613949 2029-12-21 Drug product N022545-004 8613949 2029-12-21 Drug product
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 5 of 5 · 176 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 N022545-001 TEKAMLO EQ 150MG BASE;EQ 5MG BASE TABLET / ORAL 2010-08-26 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N022545-002 TEKAMLO EQ 150MG BASE;EQ 10MG BASE TABLET / ORAL 2010-08-26 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N022545-003 TEKAMLO EQ 300MG BASE;EQ 5MG BASE TABLET / ORAL 2010-08-26 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N022545-004 TEKAMLO EQ 300MG BASE;EQ 10MG BASE TABLET / ORAL 2010-08-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022545-001 TEKAMLO EQ 150MG BASE;EQ 5MG BASE TABLET / ORAL 2010-08-26 e64feba35796…2022-09-29 23:25 UTC 2022-09 N022545-002 TEKAMLO EQ 150MG BASE;EQ 10MG BASE TABLET / ORAL 2010-08-26 e64feba35796…2022-09-29 23:25 UTC 2022-09 N022545-003 TEKAMLO EQ 300MG BASE;EQ 5MG BASE TABLET / ORAL 2010-08-26 e64feba35796…2022-09-29 23:25 UTC 2022-09 N022545-004 TEKAMLO EQ 300MG BASE;EQ 10MG BASE TABLET / ORAL 2010-08-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022545-001 TEKAMLO EQ 150MG BASE;EQ 5MG BASE TABLET / ORAL 2010-08-26 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022545-002 TEKAMLO EQ 150MG BASE;EQ 10MG BASE TABLET / ORAL 2010-08-26 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022545-003 TEKAMLO EQ 300MG BASE;EQ 5MG BASE TABLET / ORAL 2010-08-26 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022545-004 TEKAMLO EQ 300MG BASE;EQ 10MG BASE TABLET / ORAL 2010-08-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022545-001 TEKAMLO EQ 150MG BASE;EQ 5MG BASE TABLET / ORAL 2010-08-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022545-002 TEKAMLO EQ 150MG BASE;EQ 10MG BASE TABLET / ORAL 2010-08-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022545-003 TEKAMLO EQ 300MG BASE;EQ 5MG BASE TABLET / ORAL 2010-08-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022545-004 TEKAMLO EQ 300MG BASE;EQ 10MG BASE TABLET / ORAL 2010-08-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N022545-001 8613949 2029-12-21 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N022545-002 8613949 2029-12-21 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N022545-003 8613949 2029-12-21 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N022545-004 8613949 2029-12-21 Drug product c2088c7a36db…2026-09-14 22:38:34 2026-08 N022545-001 8613949 2029-12-21 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022545-002 8613949 2029-12-21 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022545-003 8613949 2029-12-21 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022545-004 8613949 2029-12-21 Drug product 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022545-001 8613949 2029-12-21 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022545-002 8613949 2029-12-21 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022545-003 8613949 2029-12-21 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022545-004 8613949 2029-12-21 Drug product caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022545-001 8613949 2029-12-21 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022545-002 8613949 2029-12-21 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022545-003 8613949 2029-12-21 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022545-004 8613949 2029-12-21 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022545-001 8613949 2029-12-21 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022545-002 8613949 2029-12-21 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022545-003 8613949 2029-12-21 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022545-004 8613949 2029-12-21 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022545-001 8613949 2029-12-21 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022545-002 8613949 2029-12-21 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022545-003 8613949 2029-12-21 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022545-004 8613949 2029-12-21 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022545-001 8613949 2029-12-21 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022545-002 8613949 2029-12-21 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022545-003 8613949 2029-12-21 Drug product fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022545-004 8613949 2029-12-21 Drug product fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022545-001 8613949 2029-12-21 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022545-002 8613949 2029-12-21 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022545-003 8613949 2029-12-21 Drug product b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022545-004 8613949 2029-12-21 Drug product b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022545-001 8613949 2029-12-21 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022545-002 8613949 2029-12-21 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022545-003 8613949 2029-12-21 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022545-004 8613949 2029-12-21 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022545-001 8613949 2029-12-21 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022545-002 8613949 2029-12-21 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022545-003 8613949 2029-12-21 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022545-004 8613949 2029-12-21 Drug product 2680178bc6a6…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.