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Details for New Drug Application (NDA): 020517
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NDA 020517 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 three patents protecting this drug. Additional details are available on the LUPRON DEPOT profile page.
The generic ingredient in LUPRON DEPOT is leuprolide acetate. There are twenty-two drug master file entries for this compound. Four 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 are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 020517
| Tradename: | LUPRON DEPOT |
| Applicant: | Abbvie Endocrine Inc |
| Ingredient: | leuprolide acetate |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 020517
Suppliers and Packaging for NDA: 020517
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517 | NDA | AbbVie Inc. | 0074-3346 | 0074-3346-03 | 1 KIT in 1 CARTON (0074-3346-03) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET |
| LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517 | NDA | AbbVie Inc. | 0074-3473 | 0074-3473-03 | 1 KIT in 1 CARTON (0074-3473-03) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 22.5MG/VIAL | ||||
| Approval Date: | Dec 22, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/VIAL | ||||
| Approval Date: | May 30, 1997 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 45MG/VIAL | ||||
| Approval Date: | Jun 17, 2011 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Jan 13, 2019 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 020517
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-002 | May 30, 1997 | Start Trial | Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-002 | May 30, 1997 | Start Trial | Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-001 | Dec 22, 1995 | Start Trial | Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-002 | May 30, 1997 | Start Trial | Start Trial |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-001 | Dec 22, 1995 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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