Details for New Drug Application (NDA): 217776
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NDA 217776 describes CETRORELIX ACETATE, which is a drug marketed by Gland, Livzon Grp, Qilu, Teva Pharms Inc, and Xiromed, and is included in five 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 217776
| Tradename: | CETRORELIX ACETATE |
| Applicant: | Qilu |
| Ingredient: | cetrorelix acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 217776
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CETRORELIX ACETATE | cetrorelix acetate | POWDER;SUBCUTANEOUS | 217776 | ANDA | Apotex Corp. | 60505-6270 | 60505-6270-1 | 1 KIT in 1 CARTON (60505-6270-1) * 1 mL in 1 VIAL, GLASS (60505-6281-0) * 1 mL in 1 SYRINGE, GLASS (60505-6276-0) |
| CETRORELIX ACETATE | cetrorelix acetate | POWDER;SUBCUTANEOUS | 217776 | ANDA | Qilu Pharmaceutical Co., Ltd. | 67184-0605 | 67184-0605-2 | 1 KIT in 1 CARTON (67184-0605-2) * 1 mL in 1 VIAL, GLASS (67184-0567-1) * 1 mL in 1 SYRINGE, GLASS (67184-0568-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | EQ 0.25MG BASE/VIAL | ||||
| Approval Date: | Apr 16, 2024 | TE: | AP | RLD: | No | ||||
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