Twynsta

NDA 22401, held by Boehringer Ingelheim. Amlodipine Besylate; Telmisartan.

As of Nov 14, 2026, NDA 22401 (Twynsta), held by Boehringer Ingelheim, was first approved by FDA on Oct 16, 2009, with 13 approved supplements and 0 published complete response letters.

First approved: Oct 16, 2009
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 16, 2009	Original applicationNew combination · Standard review	Approved	Summary Review Review Letter Label

Products

4 strengths and forms


TwynstaEQ 5MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amlodipine Besylate; Telmisartan	DiscontinuedReference drug
TwynstaEQ 10MG BASE;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amlodipine Besylate; Telmisartan	DiscontinuedReference drug
TwynstaEQ 5MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amlodipine Besylate; Telmisartan	DiscontinuedReference drug
TwynstaEQ 10MG BASE;80MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Amlodipine Besylate; Telmisartan	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Feb 1, 2018	Supplement 19Labeling · Standard review	Approved	Label Letter
Jan 13, 2016	Supplement 18Labeling · Standard review	Approved	Label Letter
Nov 19, 2015	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 12, 2014	Supplement 16Labeling · Standard review	Approved	Label Letter
Dec 11, 2014	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 14, 2012	Supplement 12Labeling · Standard review	Approved	Letter Label
Oct 19, 2012	Supplement 9Labeling	Approved	Letter Label
Oct 19, 2012	Supplement 7Labeling	Approved	Letter Label
Mar 29, 2012	Supplement 11Labeling · Standard review	Approved	Letter Label
Jan 18, 2012	Supplement 4Labeling	Approved	Label Letter
Nov 14, 2011	Supplement 10Labeling	Approved	Letter Label
Jun 6, 2011	Supplement 5Labeling	Approved	Letter Label
Jul 27, 2010	Supplement 2Labeling	Approved	Label Letter
Oct 16, 2009	Original applicationNew combination · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 22401
Drugs@FDA: Overview at FDA
Company: Boehringer Ingelheim Pharmaceuticals, Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters