Details for New Drug Application (NDA): 020011
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NDA 020011 describes LUPRON DEPOT, which is a drug marketed by Abbvie Endocrine Inc and is included in five NDAs. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the LUPRON DEPOT profile page.
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.
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 020011
| Tradename: | LUPRON DEPOT |
| Applicant: | Abbvie Endocrine Inc |
| Ingredient: | leuprolide acetate |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020011
Suppliers and Packaging for NDA: 020011
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020011 | NDA | AbbVie Inc. | 0074-3641 | 0074-3641-03 | 1 KIT in 1 CARTON (0074-3641-03) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET |
| LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020011 | NDA | AbbVie Inc. | 0074-3641 | 0074-3641-71 | 1 KIT in 1 CARTON (0074-3641-71) * 1 mL in 1 SYRINGE * 1 mL in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Oct 22, 1990 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 3.75MG | ||||
| Approval Date: | Oct 26, 1995 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020011
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020011-001 | Oct 22, 1990 | 5,643,607 | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020011-001 | Oct 22, 1990 | 4,005,063 | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020011-001 | Oct 22, 1990 | 5,330,767 | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020011-001 | Oct 22, 1990 | 5,476,663 | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020011-001 | Oct 22, 1990 | 4,954,298 | ⤷ Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020011-001 | Oct 22, 1990 | 4,728,721 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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