Details for New Drug Application (NDA): 214540
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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 214540
Tradename: | CETRORELIX ACETATE |
Applicant: | Livzon Grp |
Ingredient: | cetrorelix acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 214540
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CETRORELIX ACETATE | cetrorelix acetate | POWDER;SUBCUTANEOUS | 214540 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-558 | 71288-558-90 | 1 KIT in 1 CARTON (71288-558-90) * 2 mL in 1 VIAL, SINGLE-DOSE (71288-556-02) * 1 mL in 1 SYRINGE, GLASS (71288-557-81) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | EQ 0.25MG BASE/VIAL | ||||
Approval Date: | Apr 24, 2024 | TE: | AP | RLD: | No |
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