Details for New Drug Application (NDA): 212613
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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 212613
Tradename: | GANIRELIX ACETATE |
Applicant: | Amphastar Pharms Inc |
Ingredient: | ganirelix acetate |
Patents: | 0 |
Pharmacology for NDA: 212613
Mechanism of Action | Gonadotropin Releasing Hormone Receptor Antagonists |
Physiological Effect | Decreased GnRH Secretion |
Suppliers and Packaging for NDA: 212613
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GANIRELIX ACETATE | ganirelix acetate | INJECTABLE;INJECTION | 212613 | ANDA | Amphastar Pharmaceuticals, Inc. | 0548-5001 | 0548-5001-00 | 1 SYRINGE in 1 CARTON (0548-5001-00) / .5 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 250MCG/0.5ML | ||||
Approval Date: | Apr 7, 2022 | TE: | AP | RLD: | No |
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