Details for New Drug Application (NDA): 214540
NDA 214540 describes CETRORELIX ACETATE, which is a drug marketed by Epic Pharma Llc, Gland, Livzon Grp, Qilu, Teva Pharms Inc, and Xiromed, and is included in six NDAs. It is available from five 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. Six suppliers are listed for this compound. 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. Six 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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