Details for New Drug Application (NDA): 213829
✉ Email this page to a colleague
NDA 213829 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 213829
| Tradename: | LEUPROLIDE ACETATE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | leuprolide acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 213829
Suppliers and Packaging for NDA: 213829
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 213829 | ANDA | NorthStar RxLLC | 72603-344 | 72603-344-01 | 1 KIT in 1 CARTON (72603-344-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (72603-201-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 28 PACKET in 1 CARTON / 1 mL in 1 PACKET |
| LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 213829 | ANDA | VGYAAN Pharmaceuticals LLC | 72664-611 | 72664-611-28 | 1 KIT in 1 CARTON (72664-611-28) * 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: | Aug 13, 2021 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
