Details for New Drug Application (NDA): 212963
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NDA 212963 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 eight 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. Eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 212963
| Tradename: | LEUPROLIDE ACETATE |
| Applicant: | Eugia Pharma |
| Ingredient: | leuprolide acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 212963
Suppliers and Packaging for NDA: 212963
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 212963 | ANDA | Eugia US LLC | 55150-478 | 55150-478-01 | 1 KIT in 1 CARTON (55150-478-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (55150-338-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (60913-006-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 14MG/2.8ML (1MG/0.2ML) | ||||
| Approval Date: | Jun 6, 2022 | TE: | AP | RLD: | No | ||||
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