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 1 .
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AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-16 N022401-002 TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-16 N022401-003 TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-16 N022401-004 TWYNSTA AMLODIPINE BESYLATE; TELMISARTAN EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-16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.
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 2026-08-01 22:54:32 2026-06 N022401-001 TWYNSTA EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-10-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N022401-002 TWYNSTA EQ 10MG BASE;40MG **Federal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 a50c72e98297…2026-08-01 22:54:32 2026-06 N022401-003 TWYNSTA 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 a50c72e98297…2026-08-01 22:54:32 2026-06 N022401-004 TWYNSTA 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 a50c72e98297…
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