Home Applications 200435 Application 200435
Type ANDA
Sponsor TEVA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 5MG BASE;12.5MG;160MG No No 002 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 5MG BASE;25MG;160MG No No 003 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;160MG No No 004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;320MG No No 005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;12.5MG;160MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A200435-001 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 5MG BASE;12.5MG;160MG TABLET / ORAL 2012-09-25 A200435-002 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 5MG BASE;25MG;160MG TABLET / ORAL 2012-09-25 A200435-003 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 10MG BASE;25MG;160MG TABLET / ORAL 2012-09-25 A200435-004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 10MG BASE;25MG;320MG TABLET / ORAL 2012-09-25 A200435-005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 10MG BASE;12.5MG;160MG TABLET / ORAL 2012-09-25
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 6 of 6 · 220 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 A200435-001 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;160MG TABLET / ORAL 2012-09-25 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A200435-002 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;160MG TABLET / ORAL 2012-09-25 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A200435-003 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;160MG TABLET / ORAL 2012-09-25 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A200435-004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;320MG TABLET / ORAL 2012-09-25 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A200435-005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;160MG TABLET / ORAL 2012-09-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200435-001 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;160MG TABLET / ORAL 2012-09-25 e64feba35796…2022-09-29 23:25 UTC 2022-09 A200435-002 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;160MG TABLET / ORAL 2012-09-25 e64feba35796…2022-09-29 23:25 UTC 2022-09 A200435-003 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;160MG TABLET / ORAL 2012-09-25 e64feba35796…2022-09-29 23:25 UTC 2022-09 A200435-004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;320MG TABLET / ORAL 2012-09-25 e64feba35796…2022-09-29 23:25 UTC 2022-09 A200435-005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;160MG TABLET / ORAL 2012-09-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200435-001 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;160MG TABLET / ORAL 2012-09-25 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200435-002 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;160MG TABLET / ORAL 2012-09-25 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200435-003 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;160MG TABLET / ORAL 2012-09-25 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200435-004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;320MG TABLET / ORAL 2012-09-25 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200435-005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;160MG TABLET / ORAL 2012-09-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A200435-001 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;160MG TABLET / ORAL 2012-09-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A200435-002 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;160MG TABLET / ORAL 2012-09-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A200435-003 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;160MG TABLET / ORAL 2012-09-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A200435-004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;320MG TABLET / ORAL 2012-09-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A200435-005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;160MG TABLET / ORAL 2012-09-25 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 9825 ORIG 2012-09-27