Viewing data from:

AMINOCAPROIC ACID

ANDA

AMINOCAPROIC ACID | A213944 | RISING PHARMA HOLDINGS INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: AMICAR(TE code: AB)

API Supply Chain8 active DMFs

8 active API suppliers hold Drug Master Files for this ingredient.

DIPHARMA FRANCIS SRLAMINOCAPROIC ACID

DMF 311322016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDAMINOCAPROIC ACID

DMF 314782017

DASAMI LAB PRIVATE LTDAMINOCAPROIC ACID

DMF 329702021

MSN LIFE SCIENCES PRIVATE LTDAMINOCAPROIC ACID USP

DMF 331342018

OPTIMUS DRUGS PRIVATE LTDAMINOCAPROIC ACID

DMF 334072018

EMCURE PHARMACEUTICALS LTDAMINOCAPROIC ACID USP

DMF 343272020

SUNNY PHARMTECH INCAMINOCAPROIC ACID USP

DMF 343862020

MICRO LABS LTDAMINOCAPROIC ACID USP

DMF 350692020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 500MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 14, 2022

No patent or exclusivity listings for this strength.

#002 — 1GM

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 14, 2022

Change History (4)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Rising Pharmaceuticals acquired NDA 213944 for aminocaproic acid from Somerset Therapeutics LLC.

Old: SOMERSET THERAPS LLC

New: RISING

MODIFIEDApplicant7/1/2026

Rising Pharmaceuticals acquired aminocaproic acid NDA 213944 from Somerset Therapeutics LLC.

Old: SOMERSET THERAPS LLC

New: RISING

MODIFIEDApplicant Full Name7/1/2026

Rising Pharma Holdings Inc replaced Somerset Therapeutics LLC as the applicant for aminocaproic acid (NDA 213944).

Old: SOMERSET THERAPEUTICS LLC

New: RISING PHARMA HOLDINGS INC

MODIFIEDApplicant Full Name7/1/2026

Rising Pharma Holdings Inc replaced Somerset Therapeutics LLC as the applicant for aminocaproic acid NDA 213944, supplement 002.

Old: SOMERSET THERAPEUTICS LLC

New: RISING PHARMA HOLDINGS INC