Details for New Drug Application (NDA): 218150
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NDA 218150 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.
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 218150
| Tradename: | CETRORELIX ACETATE |
| Applicant: | Gland |
| Ingredient: | cetrorelix acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218150
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CETRORELIX ACETATE | cetrorelix acetate | POWDER;SUBCUTANEOUS | 218150 | ANDA | FRESENIUS KABI USA, LLC | 65219-292 | 65219-292-77 | 1 TRAY in 1 CARTON (65219-292-77) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (65219-290-02) * 1 mL in 1 SYRINGE (65219-286-01) |
| CETRORELIX ACETATE | cetrorelix acetate | POWDER;SUBCUTANEOUS | 218150 | ANDA | Gland Pharma Limited | 68083-600 | 68083-600-01 | 1 TRAY in 1 CARTON (68083-600-01) / 1 KIT in 1 TRAY * 1 mL in 1 VIAL, SINGLE-DOSE (68083-598-01) * 1 mL in 1 SYRINGE (68083-599-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | EQ 0.25MG BASE/VIAL | ||||
| Approval Date: | Apr 25, 2024 | TE: | AP | RLD: | No | ||||
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