Orange Book product · Brand (NDA)
AMICAR
AMINOCAPROIC ACID
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
AMINOCAPROIC ACID
Strength
250MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 015229
Product number
002
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.
- 2004AMICARBrand (NDA)
NDA 015197 · HIKMA
- 1982AMINOCAPROIC ACIDBrand (NDA)
NDA 018590 · BAXTER HLTHCARE
- —AMICARBrand (NDA)
NDA 015230 · HIKMA
- 2025AMINOCAPROIC ACIDGeneric (ANDA)
ANDA 215374 · ZENARA
- 2025AMINOCAPROIC ACIDGeneric (ANDA)
ANDA 213216 · SCIEGEN PHARMS
- 2024AMINOCAPROIC ACIDGeneric (ANDA)
ANDA 215100 · MSN
- 2023AMINOCAPROIC ACIDGeneric (ANDA)
ANDA 213213 · SUNNY
- 2023AMINOCAPROIC ACIDGeneric (ANDA)
ANDA 212938 · MSN
- 2023AMINOCAPROIC ACIDGeneric (ANDA)
ANDA 214458 · TARO
- 2022AMINOCAPROIC ACIDGeneric (ANDA)
ANDA 216464 · ANNORA PHARMA
- 2022AMINOCAPROIC ACIDGeneric (ANDA)
ANDA 216804 · AUROBINDO PHARMA
- 2022AMINOCAPROIC ACIDGeneric (ANDA)
ANDA 213944 · RISING
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.
