Details for New Drug Application (NDA): 021197

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NDA 021197 describes CETROTIDE, which is a drug marketed by Emd Serono Inc and is included in one NDA. It is available from one supplier. Additional details are available on the CETROTIDE profile page.

The generic ingredient in CETROTIDE is cetrorelix acetate. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the cetrorelix acetate profile page.

Summary for 021197

Tradename:	CETROTIDE
Applicant:	Emd Serono Inc
Ingredient:	cetrorelix acetate
Patents:	0

Suppliers and Packaging for NDA: 021197

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197	NDA	EMD Serono, Inc.	44087-1225	44087-1225-1	1 KIT in 1 CARTON (44087-1225-1) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;SUBCUTANEOUS			Strength	EQ 0.25MG BASE/VIAL
Approval Date:	Aug 11, 2000	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;SUBCUTANEOUS			Strength	EQ 3MG BASE/VIAL
Approval Date:	Aug 11, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 021197

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000	⤷ Sign Up	⤷ Sign Up
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000	⤷ Sign Up	⤷ Sign Up
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000	⤷ Sign Up	⤷ Sign Up
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-001	Aug 11, 2000	⤷ Sign Up	⤷ Sign Up
Emd Serono Inc	CETROTIDE	cetrorelix acetate	POWDER;SUBCUTANEOUS	021197-002	Aug 11, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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