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 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 020517
| Tradename: | LUPRON DEPOT |
| Applicant: | Abbvie Endocrine Inc |
| Ingredient: | leuprolide acetate |
| Patents: | 2 |
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 (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 1.5 mL in 1 SYRINGE * 1 SWAB in 1 PACKET |
| LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517 | NDA | AbbVie Inc. | 0074-3346 | 0074-3346-55 | 1 KIT in 1 CELLO PACK (0074-3346-55) * 1.5 mL in 1 SYRINGE (0074-9922-01) * 1 SWAB in 1 PACKET (0074-0009-01) * 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 | ||||
| Approval Date: | Dec 22, 1995 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30MG | ||||
| Approval Date: | May 30, 1997 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 45MG | ||||
| Approval Date: | Jun 17, 2011 | TE: | RLD: | Yes | |||||
| Patent: | 8,921,326 | Patent Expiration: | Feb 5, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | PALLIATIVE TREATMENT OF PROSTATE CANCER | ||||||||
Expired US Patents for NDA 020517
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