Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215658
Company: GLAND PHARMA LTD

Products on ANDA 215658

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GANIRELIX ACETATE	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215658

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/28/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/20/2024	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 215658

GANIRELIX ACETATE

INJECTABLE;INJECTION; 250MCG/0.5ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FYREMADEL	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AP	204246	SUN PHARM
GANIRELIX ACETATE	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AP	212613	AMPHASTAR PHARMS INC
GANIRELIX ACETATE	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AP	215658	GLAND PHARMA LTD
GANIRELIX ACETATE	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AP	216075	LUPIN LTD
GANIRELIX ACETATE	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE;INJECTION	Prescription	No	AP	214996	MEITHEAL
GANIRELIX ACETATE	GANIRELIX ACETATE	250MCG/0.5ML	INJECTABLE;INJECTION	Prescription	Yes	AP	021057	ORGANON USA ORGANON