Home Applications 200045 Application 200045
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE TABLET;ORAL EQ 150MG BASE;EQ 5MG BASE;12.5MG No No 002 AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE TABLET;ORAL EQ 300MG BASE;EQ 5MG BASE;12.5MG No No 003 AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE TABLET;ORAL EQ 300MG BASE;EQ 5MG BASE;25MG No No 004 AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE TABLET;ORAL EQ 300MG BASE;EQ 10MG BASE;12.5MG No No 005 AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE TABLET;ORAL EQ 300MG BASE;EQ 10MG BASE;25MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N200045-001 AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE EQ 150MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 N200045-002 AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE EQ 300MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 N200045-003 AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE EQ 300MG BASE;EQ 5MG BASE;25MG TABLET / ORAL 2010-12-21 N200045-004 AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE EQ 300MG BASE;EQ 10MG BASE;12.5MG TABLET / ORAL 2010-12-21 N200045-005 AMTURNIDE ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE EQ 300MG BASE;EQ 10MG BASE;25MG TABLET / ORAL 2010-12-21
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 3 of 6 · 215 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 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200045-001 AMTURNIDE EQ 150MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200045-002 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200045-003 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;25MG TABLET / ORAL 2010-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200045-004 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;12.5MG TABLET / ORAL 2010-12-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N200045-005 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;25MG TABLET / ORAL 2010-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N200045-001 AMTURNIDE EQ 150MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N200045-002 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N200045-003 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;25MG TABLET / ORAL 2010-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N200045-004 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;12.5MG TABLET / ORAL 2010-12-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N200045-005 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;25MG TABLET / ORAL 2010-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N200045-001 AMTURNIDE EQ 150MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N200045-002 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N200045-003 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;25MG TABLET / ORAL 2010-12-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N200045-004 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;12.5MG TABLET / ORAL 2010-12-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N200045-005 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;25MG TABLET / ORAL 2010-12-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N200045-001 AMTURNIDE EQ 150MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N200045-002 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N200045-003 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;25MG TABLET / ORAL 2010-12-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N200045-004 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;12.5MG TABLET / ORAL 2010-12-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N200045-005 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;25MG TABLET / ORAL 2010-12-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N200045-001 AMTURNIDE EQ 150MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N200045-002 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N200045-003 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;25MG TABLET / ORAL 2010-12-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N200045-004 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;12.5MG TABLET / ORAL 2010-12-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N200045-005 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;25MG TABLET / ORAL 2010-12-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N200045-001 AMTURNIDE EQ 150MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N200045-002 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N200045-003 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;25MG TABLET / ORAL 2010-12-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N200045-004 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;12.5MG TABLET / ORAL 2010-12-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N200045-005 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;25MG TABLET / ORAL 2010-12-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N200045-001 AMTURNIDE EQ 150MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N200045-002 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N200045-003 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;25MG TABLET / ORAL 2010-12-21 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N200045-004 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;12.5MG TABLET / ORAL 2010-12-21 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N200045-005 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;25MG TABLET / ORAL 2010-12-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N200045-001 AMTURNIDE EQ 150MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N200045-002 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;12.5MG TABLET / ORAL 2010-12-21 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N200045-003 AMTURNIDE EQ 300MG BASE;EQ 5MG BASE;25MG TABLET / ORAL 2010-12-21 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N200045-004 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;12.5MG TABLET / ORAL 2010-12-21 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N200045-005 AMTURNIDE EQ 300MG BASE;EQ 10MG BASE;25MG TABLET / ORAL 2010-12-21 5aa47cf7b7d7…
Observed Orange Book patent history# Patent history page 1 of 5 · 165 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.