Details for New Drug Application (NDA): 217957
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NDA 217957 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 is one drug master file entry 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 is one drug master file entry for this compound. Seventeen 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 | ||||
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