Details for New Drug Application (NDA): 214996
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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 214996
Tradename: | GANIRELIX ACETATE |
Applicant: | Meitheal |
Ingredient: | ganirelix acetate |
Patents: | 0 |
Pharmacology for NDA: 214996
Mechanism of Action | Gonadotropin Releasing Hormone Receptor Antagonists |
Physiological Effect | Decreased GnRH Secretion |
Suppliers and Packaging for NDA: 214996
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 214996 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-554 | 71288-554-80 | 1 BLISTER PACK in 1 CARTON (71288-554-80) / 1 SYRINGE, GLASS in 1 BLISTER PACK / .5 mL in 1 SYRINGE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 250MCG/0.5ML | ||||
Approval Date: | Jun 6, 2022 | TE: | AP | RLD: | No |
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