Details for New Drug Application (NDA): 215658
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NDA 215658 describes GANIRELIX ACETATE, which is a drug marketed by Amphastar Pharms Inc, Gland Pharma Ltd, Lupin Ltd, Meitheal, and Organon Usa Organon, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the GANIRELIX ACETATE profile page.
The generic ingredient in GANIRELIX ACETATE is ganirelix acetate. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ganirelix acetate profile page.
The generic ingredient in GANIRELIX ACETATE is ganirelix acetate. There are four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ganirelix acetate profile page.
Summary for 215658
| Tradename: | GANIRELIX ACETATE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | ganirelix acetate |
| Patents: | 0 |
Pharmacology for NDA: 215658
| Mechanism of Action | Gonadotropin Releasing Hormone Receptor Antagonists |
| Physiological Effect | Decreased GnRH Secretion |
Suppliers and Packaging for NDA: 215658
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 215658 | ANDA | Fresenius Kabi USA, LLC | 65219-028 | 65219-028-05 | 1 SYRINGE, GLASS in 1 CARTON (65219-028-05) / 1 mL in 1 SYRINGE, GLASS |
| GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 215658 | ANDA | Gland Pharma Limited | 68083-472 | 68083-472-01 | 1 BLISTER PACK in 1 CARTON (68083-472-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 250MCG/0.5ML | ||||
| Approval Date: | Feb 28, 2023 | TE: | AP | RLD: | No | ||||
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