Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021197

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CETROTIDE (CETRORELIX ACETATE)
EQ 0.25MG BASE/VIAL
Marketing Status: Prescription

Active Ingredient: CETRORELIX ACETATE
Proprietary Name: CETROTIDE
Dosage Form; Route of Administration: POWDER; SUBCUTANEOUS
Strength: EQ 0.25MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021197
Product Number: 001
Approval Date: Aug 11, 2000
Applicant Holder Full Name: EMD SERONO INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CETROTIDE (CETRORELIX ACETATE)
EQ 3MG BASE/VIAL
Marketing Status: Discontinued

Active Ingredient: CETRORELIX ACETATE
Proprietary Name: CETROTIDE
Dosage Form; Route of Administration: POWDER; SUBCUTANEOUS
Strength: EQ 3MG BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021197
Product Number: 002
Approval Date: Aug 11, 2000
Applicant Holder Full Name: EMD SERONO INC
Marketing Status:  Discontinued
Patent and Exclusivity Information