Details for New Drug Application (NDA): 215826
NDA 215826 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 eleven suppliers. Additional details are available on the LEUPROLIDE ACETATE profile page.
The generic ingredient in LEUPROLIDE ACETATE is leuprolide acetate. There is one drug master file entry for this compound. Sixteen 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 is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 215826
| Tradename: | LEUPROLIDE ACETATE |
| Applicant: | Zydus Pharms |
| Ingredient: | leuprolide acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 215826
Suppliers and Packaging for NDA: 215826
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 215826 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1769 | 70710-1769-3 | 1 KIT in 1 CARTON (70710-1769-3) * 1 VIAL, MULTI-DOSE in 1 CARTON (70710-1768-1) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70710-1897-8) |
| LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 215826 | ANDA | Zydus Lifesciences Limited | 70771-1687 | 70771-1687-3 | 1 KIT in 1 CARTON (70771-1687-3) * 1 VIAL, MULTI-DOSE in 1 CARTON (70771-1686-1) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70771-1765-8) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 14MG/2.8ML (1MG/0.2ML) | ||||
| Approval Date: | Nov 13, 2025 | TE: | AP | RLD: | No | ||||
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