Viewing data from:

CAPTOPRIL

ANDA

CAPTOPRIL | A074483 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

4 strengths0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs7 inactive

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

WOCKHARDT LTDCAPTOPRIL

DMF 80281989

QUIMICA SINTETICA SACAPTOPRIL

DMF 84601990

ZHONGFU PHARMACEUTICAL CO LTDCAPTOPRIL USP

DMF 119051996

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDCAPTOPRIL USP

DMF 143111999

MEDICHEM SACAPTOPRIL

DMF 322472017

CHANGZHOU PHARMACEUTICAL FACTORYCAPTOPRIL

DMF 338882019

KV PHARMACEUTICAL COInactiveCAPTOPRIL TABLETS, 100MG.

DMF 59581985

EGIS PHARMACEUTICALS PRIVATE LTDInactiveCAPTOPRIL

DMF 92211991

FARMHISPANIA SAInactiveCAPTOPRIL

DMF 92691991

SHANDONG WEI FANG PHARMACEUTICAL FACTORYInactiveCAPTOPRIL

DMF 97451992

MEDICHEM SAInactiveCAPTOPRIL

DMF 97701992

BORYUNG PHARMACEUTICAL CO LTDInactiveCAPTOPRIL

DMF 112281994

SINOVA PHARMACEUTICALS CO PTE LTDInactiveCAPTOPRIL

DMF 126721997

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

Products (4)

Sort:

#001 — 12.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 13, 1996

No patent or exclusivity listings for this strength.

#002 — 25MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 13, 1996

#003 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 13, 1996

#004 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 13, 1996

Change History (8)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its applicant name from "Cosette" to "Cosette Pharms NC" for Captopril NDA 074483.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its corporate name from "Cosette" to "Cosette Pharms NC" in the FDA Orange Book record for Captopril (NDA 074483).

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its listed applicant name for Captopril (ANDA 074483) from "Cosette" to "Cosette Pharms NC" in the FDA Orange Book.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals changed its corporate entity name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for the Captopril NDA 074483.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals changed its legal entity name to Cosette Pharmaceuticals NC Laboratories LLC for Captopril NDA 074483.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals updated its legal entity name to Cosette Pharmaceuticals NC Laboratories LLC for Captopril NDA 074483.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its applicant name from "Cosette" to "Cosette Pharms NC" for Captopril NDA 074483.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals changed its legal entity name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for Captopril NDA 074483.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC