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CETRORELIX ACETATE

ANDA

CETRORELIX ACETATE | A215737 | TEVA PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CETROTIDE(TE code: AP)

API Supply Chain10 active DMFs

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

MERCK HEALTHCARE KGAACETRORELIX ACETATE BULK DRUG SUBSTANCE

DMF 180772005

ALP PHARM BEIJING CO LTDCETRORELIX ACETATE

DMF 339142019

PIRAMAL PHARMA LTDCETRORELIX

DMF 345522020

SUN PHARMACEUTICAL INDUSTRIES LTDCETRORELIX ACETATE

DMF 347042020

BIOPHORE INDIA PHARMACEUTICALS PVT LTDCETRORELIX ACETATE

DMF 347522020

CHINESE PEPTIDE COCETRORELIX ACETATE

DMF 348842020

SINOPEP-ALLSINO BIOPHARMACEUTICAL CO LTDCETRORELIX ACETATE

DMF 351712020

BCN PEPTIDES SACETRORELIX

DMF 382642023

HARBIN JIXIANGLONG BIOTECH CO LTDCETRORELIX ACETATE

DMF 399862024

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)CETRORELIX ACETATE

DMF 418542025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 7, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.25MG BASE/VIAL

0 patents0 exclusivities▴

POWDER;SUBCUTANEOUS | Approved: Aug 12, 2022

No patent or exclusivity listings for this strength.