Viewing data from:

CASPOFUNGIN ACETATE

ANDA

CASPOFUNGIN ACETATE | A207092 | GLAND PHARMA LTD

2 strengths0 unique patents0 unique exclusivities

API Supply Chain8 active DMFs4 inactive

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

TAPI NL BVCASPOFUNGIN ACETATE

DMF 269782013

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDCASPOFUNGIN ACETATE

DMF 275852013

JIANGSU HENGRUI PHARMACEUTICALS CO LTDCASPOFUNGIN ACETATE

DMF 284722014

GLAND PHARMA LTDCASPOFUNGIN ACETATE

DMF 318932017

MSN LIFE SCIENCES PRIVATE LTDCASPOFUNGIN ACETATE

DMF 335322019

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDCASPOFUNGIN ACETATE (DKB)

DMF 340912019

CHENGDU YACHT BIOTECHNOLOGY CO LTDCASPOFUNGIN ACETATE

DMF 342812019

ZHEJIANG WILD WIND PHARMACEUTICAL CO LTDCASPOFUNGIN ACETATE

DMF 355732021

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveCASPOFUNGIN

DMF 227702009

LEK PHARMACEUTICALS DDInactiveCASPOFUNGIN ACETATE

DMF 232222009

XELLIA PHARMACEUTICALS APSInactiveCASPOFUNGIN (ACETATE)

DMF 271562013

SHANGHAI TECHWELL BIOPHARMACEUTICAL CO LTDInactiveCASPOFUNGIN ACETATE

DMF 296822015

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 5, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG/VIAL

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Sep 29, 2017

No patent or exclusivity listings for this strength.

#002 — 70MG/VIAL

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Sep 29, 2017

Change History (2)

Recent changes detected for this application.

MODIFIEDrs7/1/2026

Caspofungin Acetate (Gland) gained reference standard status in the Orange Book for NDA 207092.

Old: No

New: Yes

MODIFIEDrs7/1/2026

Caspofungin acetate (Gland, NDA 207092) was designated as a Reference Standard product.

Old: No

New: Yes