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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. There is one patent protecting this drug. Additional details are available on the CETROTIDE profile page.

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

Summary for NDA: 021197

Tradename:
CETROTIDE
Applicant:
Emd Serono Inc
Ingredient:
cetrorelix
Patents:1
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021197

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETROTIDE
cetrorelix
INJECTABLE;INJECTION 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.25MG BASE/ML
Approval Date:Aug 11, 2000TE:RLD:Yes
Patent:6,319,192Patent Expiration:Apr 23, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 3MG BASE/ML
Approval Date:Aug 11, 2000TE:RLD:No
Patent:6,319,192Patent Expiration:Apr 23, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION

Expired Orange Book Patents for NDA: 021197

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Emd Serono Inc
CETROTIDE
cetrorelix
INJECTABLE;INJECTION021197-001Aug 11, 20004,800,191► subscribe
Emd Serono Inc
CETROTIDE
cetrorelix
INJECTABLE;INJECTION021197-002Aug 11, 20004,800,191► subscribe
Emd Serono Inc
CETROTIDE
cetrorelix
INJECTABLE;INJECTION021197-002Aug 11, 20006,863,891► subscribe
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