Details for New Drug Application (NDA): 020708
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The generic ingredient in LUPRON DEPOT 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 020708
| Tradename: | LUPRON DEPOT |
| Applicant: | Abbvie Endocrine Inc |
| Ingredient: | leuprolide acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020708
Suppliers and Packaging for NDA: 020708
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020708 | NDA | AbbVie Inc. | 0074-3663 | 0074-3663-03 | 1 KIT in 1 CARTON (0074-3663-03) * 1.5 mL in 1 SYRINGE * 1 mL in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 11.25MG | ||||
| Approval Date: | Mar 7, 1997 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020708
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020708-001 | Mar 7, 1997 | 5,643,607 | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020708-001 | Mar 7, 1997 | 4,652,411 | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020708-001 | Mar 7, 1997 | 5,330,767 | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020708-001 | Mar 7, 1997 | 5,476,663 | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020708-001 | Mar 7, 1997 | 4,954,298 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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