Orange Book product · Brand (NDA)
MICARDIS
TELMISARTAN
At a glance
Apr 04, 2000
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 04, 2000
26 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
TELMISARTAN
Strength
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020850
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025TELMISARTANGeneric (ANDA)
ANDA 203986 · MACLEODS PHARMS LTD
- 2024TELMISARTANGeneric (ANDA)
ANDA 218157 · MANKIND PHARMA
- 2019TELMISARTANGeneric (ANDA)
ANDA 207843 · HISUN PHARM HANGZHOU
- 2017TELMISARTANGeneric (ANDA)
ANDA 207016 · MICRO LABS
- 2017TELMISARTANGeneric (ANDA)
ANDA 208605 · CADILA PHARMS LTD
- 2017TELMISARTANGeneric (ANDA)
ANDA 207882 · PRINSTON INC
- 2016TELMISARTANGeneric (ANDA)
ANDA 204164 · JUBILANT GENERICS
- 2016TELMISARTANGeneric (ANDA)
ANDA 205901 · HETERO LABS LTD V
- 2015TELMISARTANGeneric (ANDA)
ANDA 205150 · INVENTIA
- 2015TELMISARTANGeneric (ANDA)
ANDA 204415 · AMNEAL PHARMS
- 2015TELMISARTANGeneric (ANDA)
ANDA 206511 · AUROBINDO PHARMA
- 2014TELMISARTANGeneric (ANDA)
ANDA 203867 · SANDOZ
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
