Home Applications 022401 Application 022401
Type NDA
Sponsor BOEHRINGER INGELHEIM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN TABLET;ORAL EQ 5MG BASE;40MG Yes No 002 TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN TABLET;ORAL EQ 10MG BASE;40MG Yes No 003 TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN TABLET;ORAL EQ 5MG BASE;80MG Yes No 004 TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN TABLET;ORAL EQ 10MG BASE;80MG Yes Yes
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 N022401-001 TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-16 N022401-002 TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-16 N022401-003 TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-16 N022401-004 TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-16
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 N022401-001 TWYNSTA EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022401-002 TWYNSTA EQ 10MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022401-003 TWYNSTA EQ 5MG BASE;80MG TABLET / ORAL AB RLD 2009-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022401-004 TWYNSTA EQ 10MG BASE;80MG TABLET / ORAL AB RLD, RS 2009-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022401-001 TWYNSTA EQ 5MG BASE;40MG TABLET / ORAL RLD 2009-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022401-002 TWYNSTA EQ 10MG BASE;40MG TABLET / ORAL RLD 2009-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022401-003 TWYNSTA EQ 5MG BASE;80MG TABLET / ORAL RLD 2009-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022401-004 TWYNSTA EQ 10MG BASE;80MG TABLET / ORAL RLD 2009-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022401-001 TWYNSTA EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022401-002 TWYNSTA EQ 10MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022401-003 TWYNSTA EQ 5MG BASE;80MG TABLET / ORAL AB RLD 2009-10-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022401-004 TWYNSTA EQ 10MG BASE;80MG TABLET / ORAL AB RLD, RS 2009-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022401-001 TWYNSTA EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022401-002 TWYNSTA EQ 10MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022401-003 TWYNSTA EQ 5MG BASE;80MG TABLET / ORAL AB RLD 2009-10-16 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022401-004 TWYNSTA EQ 10MG BASE;80MG TABLET / ORAL AB RLD, RS 2009-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022401-001 TWYNSTA EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022401-002 TWYNSTA EQ 10MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022401-003 TWYNSTA EQ 5MG BASE;80MG TABLET / ORAL AB RLD 2009-10-16 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022401-004 TWYNSTA EQ 10MG BASE;80MG TABLET / ORAL AB RLD, RS 2009-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022401-001 TWYNSTA EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022401-002 TWYNSTA EQ 10MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022401-003 TWYNSTA EQ 5MG BASE;80MG TABLET / ORAL AB RLD 2009-10-16 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022401-004 TWYNSTA EQ 10MG BASE;80MG TABLET / ORAL AB RLD, RS 2009-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022401-001 TWYNSTA EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022401-002 TWYNSTA EQ 10MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022401-003 TWYNSTA EQ 5MG BASE;80MG TABLET / ORAL AB RLD 2009-10-16 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022401-004 TWYNSTA EQ 10MG BASE;80MG TABLET / ORAL AB RLD, RS 2009-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022401-001 TWYNSTA EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022401-002 TWYNSTA EQ 10MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022401-003 TWYNSTA EQ 5MG BASE;80MG TABLET / ORAL AB RLD 2009-10-16 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022401-004 TWYNSTA EQ 10MG BASE;80MG TABLET / ORAL AB RLD, RS 2009-10-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022401-001 TWYNSTA EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022401-002 TWYNSTA EQ 10MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022401-003 TWYNSTA EQ 5MG BASE;80MG TABLET / ORAL AB RLD 2009-10-16 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022401-004 TWYNSTA EQ 10MG BASE;80MG TABLET / ORAL AB RLD, RS 2009-10-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022401-001 TWYNSTA EQ 5MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022401-002 TWYNSTA EQ 10MG BASE;40MG TABLET / ORAL AB RLD 2009-10-16 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022401-003 TWYNSTA EQ 5MG BASE;80MG TABLET / ORAL AB RLD 2009-10-16 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022401-004 TWYNSTA EQ 10MG BASE;80MG TABLET / ORAL AB RLD, RS 2009-10-16 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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0597-0124 Twynsta telmisartan/amlodipine Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0124 Twynsta telmisartan/amlodipine Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0125 Twynsta telmisartan/amlodipine Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0125 Twynsta telmisartan/amlodipine Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0126 Twynsta telmisartan/amlodipine Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0126 Twynsta telmisartan/amlodipine Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0127 Twynsta telmisartan/amlodipine Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current 0597-0127 Twynsta telmisartan/amlodipine Boehringer Ingelheim Pharmaceuticals, Inc. NDA Current