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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

DEGARELIX ACETATE

ANDA

Tentative Approval

DEGARELIX ACETATE | A215791 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD.

API Supply Chain6 active DMFs2 inactive

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

SHENZHEN JYMED TECHNOLOGY CO LTDDEGARELIX ACETATE

DMF 335502019

AURO PEPTIDES LTDDEGARELIX

DMF 350782020

JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTDDEGARELIX ACETATE NON-STERILE BULK DRUG SUBSTANCE

DMF 362162022

FRESENIUS KABI IPSUM SRLDEGARELIX ACETATE

DMF 364992023

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

DMF 409702024

SUZHOU TIANMA PHARMA GROUP TIANJI BIO-PHARMACEUTICAL CO LTDDEGARELIX ACETATE

DMF 432152025

APICORE LLCInactiveDEGARELIX ACETATE MANNITOL PREMIX 29% (STERILE)

DMF 370052023

APICORE LLCInactiveDEGARELIX ACETATE MANNITOL PREMIX 45% (STERILE)

DMF 371132023

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

Products (1)

#002 — 80MG

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NJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | TA Date: 2025-08-18 00:00:00

No patent or exclusivity listings for this strength.