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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 215737


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NDA 215737 describes CETRORELIX ACETATE, which is a drug marketed by Gland, Livzon Grp, Qilu, and Teva Pharms Inc, and is included in four NDAs. It is available from six suppliers. Additional details are available on the CETRORELIX ACETATE profile page.

The generic ingredient in CETRORELIX ACETATE 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 215737
Tradename:CETRORELIX ACETATE
Applicant:Teva Pharms Inc
Ingredient:cetrorelix acetate
Patents:0
Suppliers and Packaging for NDA: 215737
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CETRORELIX ACETATE cetrorelix acetate POWDER;SUBCUTANEOUS 215737 ANDA Teva Pharmaceuticals, Inc. 0480-5795 0480-5795-08 1 TRAY in 1 CARTON (0480-5795-08) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (0480-3583-01) * 1 mL in 1 SYRINGE (0480-3584-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBCUTANEOUSStrengthEQ 0.25MG BASE/VIAL
Approval Date:Aug 12, 2022TE:APRLD:No

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