Home Applications 201593 Application 201593
Type ANDA
Sponsor TORRENT 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;12.5MG;160MG No No 004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;160MG No No 005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN TABLET;ORAL EQ 10MG BASE;25MG;320MG 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 A201593-001 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 5MG BASE;12.5MG;160MG TABLET / ORAL 2015-06-03 A201593-002 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 5MG BASE;25MG;160MG TABLET / ORAL 2015-06-03 A201593-003 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 10MG BASE;12.5MG;160MG TABLET / ORAL 2015-06-03 A201593-004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 10MG BASE;25MG;160MG TABLET / ORAL 2015-06-03 A201593-005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN EQ 10MG BASE;25MG;320MG TABLET / ORAL 2015-06-03
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 A201593-001 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;160MG TABLET / ORAL 2015-06-03 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A201593-002 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;160MG TABLET / ORAL 2015-06-03 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A201593-003 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;160MG TABLET / ORAL 2015-06-03 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A201593-004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;160MG TABLET / ORAL 2015-06-03 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A201593-005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;320MG TABLET / ORAL 2015-06-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201593-001 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;160MG TABLET / ORAL 2015-06-03 e64feba35796…2022-09-29 23:25 UTC 2022-09 A201593-002 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;160MG TABLET / ORAL 2015-06-03 e64feba35796…2022-09-29 23:25 UTC 2022-09 A201593-003 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;160MG TABLET / ORAL 2015-06-03 e64feba35796…2022-09-29 23:25 UTC 2022-09 A201593-004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;160MG TABLET / ORAL 2015-06-03 e64feba35796…2022-09-29 23:25 UTC 2022-09 A201593-005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;320MG TABLET / ORAL 2015-06-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201593-001 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;160MG TABLET / ORAL 2015-06-03 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201593-002 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;160MG TABLET / ORAL 2015-06-03 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201593-003 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;160MG TABLET / ORAL 2015-06-03 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201593-004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;160MG TABLET / ORAL 2015-06-03 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201593-005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;320MG TABLET / ORAL 2015-06-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201593-001 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;12.5MG;160MG TABLET / ORAL 2015-06-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201593-002 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 5MG BASE;25MG;160MG TABLET / ORAL 2015-06-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201593-003 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;12.5MG;160MG TABLET / ORAL 2015-06-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201593-004 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;160MG TABLET / ORAL 2015-06-03 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A201593-005 AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE EQ 10MG BASE;25MG;320MG TABLET / ORAL 2015-06-03 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 13668-325 Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide Torrent Pharmaceuticals Limited ANDA Current 13668-325 Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide Torrent Pharmaceuticals Limited ANDA Current 13668-326 Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide Torrent Pharmaceuticals Limited ANDA Current 13668-326 Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide Torrent Pharmaceuticals Limited ANDA Current 13668-327 Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide Torrent Pharmaceuticals Limited ANDA Current 13668-327 Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide Torrent Pharmaceuticals Limited ANDA Current 13668-328 Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide Torrent Pharmaceuticals Limited ANDA Current 13668-328 Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide Torrent Pharmaceuticals Limited ANDA Current 13668-329 Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide Torrent Pharmaceuticals Limited ANDA Current 13668-329 Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide Torrent Pharmaceuticals Limited ANDA Current 70518-1220 Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide REMEDYREPACK INC. ANDA Current 70518-1220 Amlodipine, Valsartan and Hydrochlorothiazide Amlodipine, Valsartan and Hydrochlorothiazide REMEDYREPACK INC. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 32121 ORIG 2015-06-10 32120 ORIG 2014-11-04