Details for New Drug Application (NDA): 217437
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NDA 217437 describes LEUPROLIDE ACETATE, which is a drug marketed by Amneal, Eugia Pharma, Genzyme, Meitheal, Ph Health, Sandoz, Somerset Theraps Llc, Sun Pharm, UBI, Zydus Pharms, and Invagen Pharms, and is included in eleven NDAs. It is available from twelve suppliers. Additional details are available on the LEUPROLIDE ACETATE profile page.
The generic ingredient in LEUPROLIDE ACETATE is leuprolide acetate. There are twenty-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
The generic ingredient in LEUPROLIDE ACETATE is leuprolide acetate. There are twenty-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 217437
| Tradename: | LEUPROLIDE ACETATE |
| Applicant: | Ph Health |
| Ingredient: | leuprolide acetate |
| Patents: | 0 |
Pharmacology for NDA: 217437
| Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 217437
Suppliers and Packaging for NDA: 217437
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 217437 | ANDA | Endo USA, Inc. | 42023-259 | 42023-259-00 | 1 CARTON in 1 KIT (42023-259-00) / 1 VIAL, MULTI-DOSE in 1 CARTON (42023-259-01) / 2.8 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 14MG/2.8ML (1MG/0.2ML) | ||||
| Approval Date: | Jun 9, 2025 | TE: | RLD: | No | |||||
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