Home Applications 091235 Application 091235
Type ANDA
Sponsor TEVA PHARMS USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN TABLET;ORAL EQ 5MG BASE;160MG No No 002 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN TABLET;ORAL EQ 10MG BASE;160MG No No 003 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN TABLET;ORAL EQ 5MG BASE;320MG No No 004 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN TABLET;ORAL EQ 10MG BASE;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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091235-001 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 A091235-002 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 A091235-003 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 A091235-004 AMLODIPINE BESYLATE AND VALSARTAN AMLODIPINE BESYLATE; VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30
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 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 2019-12-13 00:20 UTC 2019-12 A091235-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091235-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091235-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091235-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091235-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091235-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091235-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091235-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091235-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091235-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091235-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091235-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091235-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091235-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091235-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091235-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091235-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A091235-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A091235-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A091235-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091235-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A091235-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A091235-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A091235-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091235-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A091235-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A091235-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A091235-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091235-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A091235-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A091235-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A091235-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091235-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL 2015-03-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A091235-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL 2015-03-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A091235-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL 2015-03-30 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A091235-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL 2015-03-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091235-001 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;160MG TABLET / ORAL AB 2015-03-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A091235-002 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;160MG TABLET / ORAL AB 2015-03-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A091235-003 AMLODIPINE BESYLATE AND VALSARTAN EQ 5MG BASE;320MG TABLET / ORAL AB 2015-03-30 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A091235-004 AMLODIPINE BESYLATE AND VALSARTAN EQ 10MG BASE;320MG TABLET / ORAL AB 2015-03-30 ea99ee380514…
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 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0093-7690 Amlodipine and Valsartan Amlodipine and Valsartan Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7692 Amlodipine and Valsartan Amlodipine and Valsartan Teva Pharmaceuticals USA, Inc. ANDA Current 0093-7693 Amlodipine and Valsartan Amlodipine and Valsartan Teva Pharmaceuticals USA, Inc. ANDA Current