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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021057

GANIRELIX ACETATE (GANIRELIX ACETATE)
250MCG/0.5ML
Marketing Status: Prescription
Active Ingredient: GANIRELIX ACETATE
Proprietary Name: GANIRELIX ACETATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 250MCG/0.5ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AP
Application Number: N021057
Product Number: 001
Approval Date: Jul 29, 1999
Applicant Holder Full Name: ORGANON USA LLC A SUB OF ORGANON AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information
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