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ICATIBANT ACETATE

ANDA

ICATIBANT ACETATE | A210118 | TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: FIRAZYR(TE code: AP)

API Supply Chain16 active DMFs

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

BACHEM AGICATIBANT ACETATE

DMF 208622007

CHENGDU SHENGNUO BIOPHARM CO LTDICATIBANT ACETATE

DMF 284962015

BCN PEPTIDES SAICATIBANT ACETATE

DMF 292132015

AMBIO INCICATIBANT ACETATE (NON-STERILE)

DMF 292252015

TAPI NL BVICATIBANT ACETATE

DMF 304762016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDICATIBANT ACETATE

DMF 305262016

MSN LIFE SCIENCES PRIVATE LTDICATIBANT ACETATE

DMF 306722016

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDICATIBANT ACETATE

DMF 311062016

MATRIX PHARMACORP PRIVATE LTDICATIBANT ACETATE

DMF 312602016

SUN PHARMACEUTICAL INDUSTRIES LTDICATIBANT ACETATE

DMF 315502018

DR REDDYS LABORATORIES LTDICATIBANT ACETATE

DMF 321562017

CIPLA LTDICATIBANT ACETATE

DMF 323182018

USV PRIVATE LTDICATIBANT ACETATE

DMF 332122018

AURO PEPTIDES LTDICATIBANT ACETATE

DMF 337502019

ALEMBIC PHARMACEUTICALS LTDICATIBANT ACETATE

DMF 344502020

FRESENIUS KABI IPSUM SRLICATIBANT ACETATE

DMF 381902024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 6, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Jul 15, 2019

No patent or exclusivity listings for this strength.