Details for New Drug Application (NDA): 217957
✉ Email this page to a colleague
NDA 217957 describes LEUPROLIDE ACETATE, which is a drug marketed by Amneal, Eugia Pharma, Genzyme, Meitheal, Rk Pharma, Sandoz, Sun Pharm, UBI, and Invagen Pharms, and is included in nine NDAs. It is available from ten 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. Fourteen 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. Fourteen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 217957
| Tradename: | LEUPROLIDE ACETATE |
| Applicant: | Ubi |
| Ingredient: | leuprolide acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 217957
Suppliers and Packaging for NDA: 217957
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 217957 | ANDA | PAI Holdings, LLC dba PAI Pharma | 0121-2106 | 0121-2106-02 | 1 KIT in 1 CARTON (0121-2106-02) * 1 VIAL, MULTI-DOSE in 1 CARTON (0121-1053-02) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (0121-2105-01) |
| LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 217957 | ANDA | UBI Pharma Inc. | 72843-591 | 72843-591-99 | 1 KIT in 1 CARTON (72843-591-99) * 1 VIAL, MULTI-DOSE in 1 CARTON (72843-590-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 14MG/2.8ML (1MG/0.2ML) | ||||
| Approval Date: | Oct 17, 2024 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
