Details for New Drug Application (NDA): 212613
NDA 212613 describes GANIRELIX ACETATE, which is a drug marketed by Amphastar Pharms Inc, Gland, Lupin, Meitheal, Organon Usa Organon, Qilu, and Tris Pharma Inc, and is included in seven NDAs. It is available from nine suppliers. Additional details are available on the GANIRELIX ACETATE profile page.
The generic ingredient in GANIRELIX ACETATE is ganirelix acetate. There is one drug master file entry for this compound. Ten 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 is one drug master file entry for this compound. Ten 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 | ||||
Complete Access Available with Subscription
